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The infection is more frequent in HIV+ long-term travelers (Harms 2003 buy 10mg provera with amex women's health shaving tips, Weitzel 2005) buy cheap provera 2.5 mg online menstrual cycle 5 days late. Due to the infection’s poten- tially extended latency period cheap provera 10mg fast delivery menstruation with blood clots, symptoms can occur long after exposure in endemic areas purchase provera 2.5mg free shipping women's health center southington ct. Diagnosis is challenging, requiring cooperation with a specialized center. Severely immunocompromised HIV+ patients must be informed of the risk of leishmaniasis even when traveling to Mediterranean countries. Preventive measures against mosquito bites should be followed (see above); because of the vector’s small size, the use of impregnated mosquito nets of small mesh size is advisable. Cutaneous leishmaniasis does not seem to occur more frequently. In most tropical and subtropical regions, the risk of tuberculosis is higher than in Europe. Before and after long-term travel to such areas, it is advisable to determine the TB reactivity by interferon-gamma release assay (IGRA) of PPD skin test (Rieder 2001). Patients with a positive reaction or with a known high-risk exposure and no further signs of active tuberculosis should receive a course of treatment for latent tuberculosis (see chapter on Tuberculosis). HIV+ travelers should avoid risk areas such as hospitals, prisons or homeless shelters or wear adequate facemasks. Endemic mycoses Endemic mycoses outside endemic areas are rare. Nevertheless, they are able to cause life-threatening opportunistic infections in HIV+ patients even years after a stay in an endemic area. Most agents of endemic mycoses are thought to enter the pulmonary tract after inhalation of infective spores. In areas endemic for Penicillium marneffei (South East Asia, Southern China) and Coccidioides immitis (south-west parts of the USA, parts of Central and South America), increased exposure to dust or soil should be avoided (e. Histoplasma capsulatum is prevalent worldwide in soil contaminated with bird and bat droppings. Exposure might happen during eco- or adventure-tourism and should be avoided. Depending on the expected pathogen, either fluconazole or itracona- zole should be prescribed. Another fungus that can cause severe infections is Sporothrix schenkii. This pathogen, which occurs worldwide, enters the body through cutaneous lesions. Wearing gloves while working with plants, hay, or peat moss can reduce the sporotrichosis risk. Sexually transmitted diseases Traveling is associated with more frequent sexual encounters and less frequent use of condoms (Matteelli 2001). The risk of STDs is substantially increased (Richens 2006). Other parasites The following parasitic pathogens are relevant to HIV+ travelers: • Strongyloides stercoralis is prevalent in most tropical and subtropical areas. The par- asite is transmitted by cutaneous larval invasion after skin contact with contami- nated soil. In HIV+ patients, there is the risk of a “hyperinfection syndrome” with a high fatality rate (Gompels 1991). Corticosteroids seems to be an important risk factor, as they may increase larval maturation triggering a cycle of massive autoin- fection. The protozoon that causes Chagas disease is transmitted by triatomine bugs but oral transmissions via contaminated fruit or sugarcane juice have also been reported. Chagas disease can persist asymptomatically for many years and reactivate in severely immunocom- promised patients. In these cases, lesions radiologically resembling cerebral toxo- plasmosis are found in the central nervous system (Rocha 1994). Severe infections, clinically mimicking malaria or manifesting as fever of unknown origin, mainly occur in patients after splenectomy, but have also been reported in severely immunocompromised patients (Falagas 1996). Traveling with HIV 511 • Free-living amoeba (Acanthamoeba sp. In immunocompromised patients, these organisms are capable of causing severe infections of the central nervous system (granulomatous encephalitis) as well as local infections of the skin and cornea (Sison 1995). In HIV+ patients, schistosomiasis treatment is less effective (Kallestrup 2006). The chronic stimulation of the immune system has a negative influence on HIV infection (Secor 2006). HIV+ travelers should avoid freshwater contact in endemic areas. Medical problems after traveling Every disease occurring during or after traveling should be checked in a timely manner. Because most tropical diseases are quite rare in temperate countries, diag- nosis is often delayed. An analysis of imported visceral leishmaniasis in Germany revealed a median time span of 85 days until the diagnosis was established (Weitzel 2005). Furthermore, tropical diseases often manifest atypically (Karp 1999). In any event, differential diagnoses of diseases are very broad. After traveling abroad the clinical and diagnostic situation can become even more complex, calling for a close cooperation of HIV and Tropical Medicine specialists. Sexual transmission of intestinal parasites in men who have sex with men. Lack of effect of doxycycline on trough concentrations of protease inhibitors or non-nucleoside reverse transcriptase inhibitors in HIV-infected patients. Antiretroviral agents and prevention of malaria in HIV-infected Ugandan chil- dren. Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). Update: Prevention of hepatitis A after exposure to hepatitis A virus and in international travelers.. Bacterial enteric infections in persons infected with human immunodeficiency virus. Increased prevalence of severe malaria in HIV-infected adults in South Africa. Babesiosis in patients with AIDS: a chronic infection presenting as fever of unknown origin. Consequences of HIV infection on malaria and therapeutic implications: a sys- tematic review. Franco-Paredes C, Hidron A, Tellez I, Lesesne J, Del Rio C. HIV infection and travel: pretravel recommendations and health-related risks. Disseminated strongyloidiasis in AIDS: uncommon but important. Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-infected women receiving cotrimoxazole prophylaxis: a multicenter randomized placebo-controlled trial. Schistosomiasis and HIV in rural Zimbabwe: efficacy of treatment of schis- tosomiasis in individuals with HIV coinfection. Kaplan JE, Hu DJ, Holmes KK, Jaffe HW, Masur H, De Cock KM.

The plot allows viewers to see the heterogeneity among the results of the studies best provera 2.5mg menstruation 28 days. The results of individual studies are shown as squares centered on each study’s point estimate cheap 10mg provera otc women's health center santa cruz. A horizontal line runs through each square to show each study’s confidence interval—usually purchase provera 10mg free shipping pregnancy week calculator, but not always generic 5 mg provera overnight delivery menstruation gastrointestinal problems, a 95% confidence interval. The overall estimate from the meta-analysis and its confidence interval are represented as a diamond. The center of the diamond is at the pooled point estimate, and its horizontal tips show the confidence interval. Disease-modifying drugs for multiple sclerosis Page 100 of 120 Final Report Update 1 Drug Effectiveness Review Project Funnel plot: A graphical display of some measure of study precision plotted against effect size that can be used to investigate whether there is a link between study size and treatment effect. Half- life: The time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%. Harms: See Adverse Event Hazard ratio: The increased risk with which one group is likely to experience an outcome of interest. For example, if the hazard ratio for death for a treatment is 0. Head-to-head trial: A trial that directly compares one drug in a particular class or group with another in the same class or group. Health outcome: The result of a particular health care practice or intervention, including the ability to function and feelings of well-being. For individuals with chronic conditions – where cure is not always possible – results include health-related quality of life as well as mortality. Heterogeneity: The variation in, or diversity of, participants, interventions, and measurement of outcomes across a set of studies. I is the proportion of total variability across studies that is due to heterogeneity and not chance. It is calculated as (Q-(n- 1))/Q, where n is the number of studies. Incidence: The number of new occurrences of something in a population over a particular period of time, e. Indication: A term describing a valid reason to use a certain test, medication, procedure, or surgery. In the United States, indications for medications are strictly regulated by the Food and Drug Administration, which includes them in the package insert under the phrase "Indications and Usage". Indirect analysis: The practice of using data from trials comparing one drug in a particular class or group with another drug outside of that class or group or with placebo and attempting to draw conclusions about the comparative effectiveness of drugs within a class or group based on that data. For example, direct comparisons between drugs A and B and between drugs B and C can be used to make an indirect comparison between drugs A and C. Intention to treat: The use of data from a randomized controlled trial in which data from all randomized patients are accounted for in the final results. Trials often incorrectly report results as being based on intention to treat despite the fact that some patients are excluded from the analysis. Internal validity: The extent to which the design and conduct of a study are likely to have prevented bias. Generally, the higher the interval validity, the better the quality of the study publication. Inter-rater reliability: The degree of stability exhibited when a measurement is repeated under identical conditions by different raters. Intermediate outcome: An outcome not of direct practical importance but believed to reflect outcomes that are important. For example, blood pressure is not directly important to patients but it is often used as an outcome in clinical trials because it is a risk factor for stroke and myocardial infarction (hear attack). Masking: See Blinding Mean difference: A method used to combine measures on continuous scales (such as weight) where the mean, standard deviation, and sample size are known for each group. Meta-analysis: The use of statistical techniques in a systematic review to integrate the results of included studies. Although the terms are sometimes used interchangeably, meta-analysis is not synonymous with systematic review. However, systematic reviews often include meta-analyses. Meta-regression: A technique used to explore the relationship between study characteristics (for example, baseline risk, concealment of allocation, timing of the intervention) and study results (the magnitude of effect observed in each study) in a systematic review. Mixed treatment comparison meta analysis: A meta-analytic technique that simultaneously compares multiple treatments (typical 3 or more) using both direct and indirect evidence. The multiple treatments form a network of treatment comparisons. Also called multiple treatment comparisons, network analysis, or umbrella reviews. Monotherapy: the use of a single drug to treat a particular disorder or disease. Multivariate analysis: Measuring the impact of more than one variable at a time while analyzing a set of data. N-of-1 trial: A randomized trial in an individual to determine the optimum treatment for that individual. Noninferiority trial: A trial designed to determine whether the effect of a new treatment is not worse than a standard treatment by more than a prespecified amount. Nonrandomized study: Any study estimating the effectiveness (harm or benefit) of an intervention that does not use randomization to allocate patients to comparison groups. There are many types of nonrandomized studies, including cohort studies, case-control studies, and before- after studies. Null hypothesis: The statistical hypothesis that one variable (for example, treatment to which a participant was allocated) has no association with another variable or set of variables. Number needed to harm: The number of people who would need to be treated over a specific period of time before one bad outcome of the treatment will occur. The number needed to harm (NNH) for a treatment can be known only if clinical trials of the treatment have been performed. Number needed to treat: An estimate of how many persons need to receive a treatment before one person would experience a beneficial outcome. Observational study: A type of nonrandomized study in which the investigators do not seek to intervene, instead simply observing the course of events. Odds ratio: The ratio of the odds of an event in one group to the odds of an event in another group. Off-label use: When a drug or device is prescribed outside its specific FDA-approved indication, to treat a condition or disease for which it is not specifically licensed. Outcome: The result of care and treatment and/ or rehabilitation. In other words, the change in health, functional ability, symptoms or situation of a person, which can be used to measure the Disease-modifying drugs for multiple sclerosis Page 102 of 120 Final Report Update 1 Drug Effectiveness Review Project effectiveness of care/treatment/rehabilitation. Researchers should decide what outcomes to measure before a study begins; outcomes are then assessed at the end of the study. Outcome measure: Is the way in which an outcome is evaluated---the device (scale) used for measuring. One-tailed test (one-sided test): A hypothesis test in which the values that reject the null hypothesis are located entirely in one tail of the probability distribution. For example, testing whether one treatment is better than another (rather than testing whether one treatment is either better or worse than another). Open-label trial: A clinical trial in which the investigator and participant are aware which intervention is being used for which participant (that is, not blinded).

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Schedule II opioid substances which include fentanyl 5mg provera with visa breast cancer 3 cm tumor, hydromorphone generic 5mg provera free shipping menstruation vs pregnancy symptoms, methadone buy 10mg provera with visa menopause youngest age, morphine best 10 mg provera breast cancer bows, oxycodone, and oxymorphone have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high content of fentanyl in the patches (DURAGESIC ) may be a particular target for abuse and diversion. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. Long-acting opioid analgesics 55 of 74 Final Update 6 Report Drug Effectiveness Review Project Active Trade ingredient name(s) Boxed warnings Fentanyl Duragesic Because serious or life-threatening hypoventilation could occur, (Continued) (Continued) DURAGESIC (fentanyl transdermal system) is contraindicated: • in patients who are not opioid-tolerant • in the management of acute pain or in patients who require opioid analgesia for a short period of time • in the management of post-operative pain, including use after out-patient or day surgeries (e. Patients receiving DURAGESIC and any CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted (see CLINICAL PHARMACOLOGY – Drug Interactions, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION for further information). DURAGESIC should be administered to children only if they are opioid-tolerant and 2 years of age or older (see PRECAUTIONS Pediatric Use). Use in non-opioid tolerant patients may lead to fatal respiratory depression. Overestimating the DURAGESIC dose when converting patients from another opioid medication can result in fatal overdose with the first dose (see DOSAGE And ADMINISTRATON – Initial DURAGESIC Dose Selection). Due to the mean half-life of approximately 20-27 hours, patients who are thought to have had a serious adverse event, including overdose, will require monitoring and treatment for at least 24 hours. This risk should be considered when administering, prescribing, or dispensing DURAGESIC in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Long-acting opioid analgesics 56 of 74 Final Update 6 Report Drug Effectiveness Review Project Active Trade ingredient name(s) Boxed warnings Fentanyl Duragesic Persons at increased risk for opioid abuse include those with a (Continued) (Continued) personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require intensive monitoring for signs of misuse, abuse or addiction. Do not use a DURAGESIC patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way. There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death. Long-acting opioid analgesics 57 of 74 Final Update 6 Report Drug Effectiveness Review Project Active Trade ingredient name(s) Boxed warnings Hydromorphone Exalgo WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE Potential for Abuse EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing EXALGO in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Proper Patient Selection EXALGO is an extended release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg of oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg of oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer. Fatal respiratory depression could occur in patients who are not opioid tolerant. Limitations of Use EXALGO is not indicated for the management of acute or postoperative pain. Taking broken, chewed, dissolved or crushed EXALGO or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone. Long-acting opioid analgesics 58 of 74 Final Update 6 Report Drug Effectiveness Review Project Active Trade ingredient name(s) Boxed warnings Methadone Dolophine Deaths, cardiac and respiratory, have been reported during initiation and conversion of pain patients to methadone treatment from treatment with other opioid agonists. It is critical to understand the pharmacokinetics of methadone when converting patients from other opioids (see DOSAGE AND ADMINISTRATION). Particular vigilance is necessary during treatment initiation, during conversion from one opioid to another, and during dose titration. Respiratory depression is the chief hazard associated with methadone hydrochloride administration. These characteristics can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration. In addition, cases of QT interval prolongation and serious arrhythmia (torsades de pointes) have been observed during treatment with methadone. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Methadone treatment for analgesic therapy in patients with acute or chronic pain should only be initiated if the potential analgesic or palliative care benefit of treatment with methadone is considered and outweighs the risks. Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid Addiction Code of Federal Regulations, Title 42, Sec 8 Methadone products when used for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor) certified by the Substance Abuse and Mental Health Services Administration and approved by the designated state authority. Certified treatment programs shall dispense and use methadone in oral form only and according to the treatment requirements stipulated in the Federal Opioid Treatment Standards (42 CFR 8. See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment. Failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program approval, and injunction precluding operation of the program. Long-acting opioid analgesics 59 of 74 Final Update 6 Report Drug Effectiveness Review Project Active Trade ingredient name(s) Boxed warnings Morphine Avinza WARNING: AVINZA capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. THE CAPSULE BEADS ARE NOT TO BE CHEWED, CRUSHED, OR DISSOLVED DUE TO THE RISK OF RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE. PATIENTS MUST NOT CONSUME ALCOHOLIC BEVERAGES WHILE ON AVINZA THERAPY. ADDITIONALLY, PATIENTS MUST NOT USE PRESCRIPTION OR NON-PRESCRIPTION MEDICATIONS CONTAINING ALCOHOL WHILE ON AVINZA THERAPY. CONSUMPTION OF ALCOHOL WHILE TAKING AVINZA MAY RESULT IN THE RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE. This should be considered when prescribing or dispensing KADIAN in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Ingestion of these capsules or of the pellets within the capsules may cause fatal respiratory depression when administered to patients not already tolerant to high doses of opioids. The pellets in the capsules are not to be chewed, crushed or dissolved due to the risk of rapid release and absorption of a potentially fatal dose of morphine Morphine Oramorph NOTE: THE SUSTAINED RELEASE OF MORPHINE FROM SR ORAMORPH SR SHOULD BE TAKEN INTO CONSIDERATION IN THE EVENT OF AN OVERDOSAGE. Long-acting opioid analgesics 60 of 74 Final Update 6 Report Drug Effectiveness Review Project Active Trade ingredient name(s) Boxed warnings Morphine sulfate Embeda™ WARNING See full prescribing information for complete boxed and naltrexone warning. The pellets in the capsules are not to be crushed, dissolved, or chewed. Misuse or abuse of EMBEDA™ by tampering with the formulation, crushing or chewing the pellets, causes the rapid release and absorption of both morphine and naltrexone. The resulting morphine dose may be fatal, particularly in opioid-naïve individuals. In opioid-tolerant individuals, the absorption of naltrexone may increase the risk of precipitating withdrawal. Long-acting opioid analgesics 61 of 74 Final Update 6 Report Drug Effectiveness Review Project Active Trade ingredient name(s) Boxed warnings Oxycodone OxyContin WARNING: IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR ABUSE OxyContin contains oxycodone which is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

With the new knowledge of the incredibly high turnover of the virus and the relentless daily destruction of CD4 T cells generic 10mg provera with mastercard women's health center west bloomfield, there was no longer any consideration of a latent phase – and no life without antiretroviral therapy provera 5mg fast delivery women's health zambia. In many centers almost every patient was treated with ART discount provera 2.5 mg with mastercard menstruation large clots. Within only three years buy 2.5mg provera amex menstrual 2 days late, 1994-1997, the proportion of untreated patients in Europe decreased from 37% to barely 9%, whilst the pro- portion of patients on ART rose from 2% to 64% (Kirk 1998). By June 1996, a third drug class was introduced when the first non-nucleoside reverse transcriptase inhibitor, nevirapine, was licensed. One now had a great selection of medications at hand. Within only four years, between 1994 and 1998, the incidence of AIDS in Europe was reduced from 30. Some of the most feared opportunistic infections now occurred only rarely (Mocroft 2000). HIV- specialized ophthalmologists began looking for new areas of work. The large OI trials, planned only a few months before, faltered due to a lack of patients. Hospices, which had been receiving substantial donations, shut down or changed their focus. The first patients began to leave the hospices and went back to work; ambulatory nursing services shut down. However, in early 1997, some patients began to complain of an increasingly fat stomach, but was this not a good sign after years of wasting and supplementary nutrition? The lower viremia was thought to use up far less energy. It was assumed that, because patients were less depressed and generally healthier, they would eat more. At most, it was slightly disturbing that the patients retained thin faces. However, more and more patients also began to complain about the high pill burden. In June 1997, the FDA published the first warning about the development of diabetes mellitus associated with the use of PIs. In February 1998, CROI in Chicago finally brought home the realization among clinicians that PIs were perhaps not as selective as had long been believed. One poster after another, indeed whole walls of pictures, showed fat abdomens, buffalo humps, thin legs and faces. Lipodystrophy has become an ubiquitous term in HIV medicine today. However, our understanding of the reasons and mechanisms behind this phenomenon remains incomplete. Fortunately, lipodystrophy prevalence has decreased, with the introduction of new antiretroviral drug classes. In 1997, it was estimated that viral suppression with a maximum duration of three years was nec- essary; it was predicted that all infected cells would die in this time. Since then, the duration has constantly been adjusted upwards. Estimates evolved upwards to around 60 to 70 years (Silicano 2003). These numbers show one thing: HIV will not be cured with standard ART. More recent studies have come to the sobering conclusion that HIV remains detectable in latent infected cells, even after long-term suppression. And Timothy Brown, the only person up to now who has been cured from HIV infec- tion (by an allogenous stem cell transplantation that transferred a rare genetic vari- ation to his immune system) remains a singular case. In fact, today’s reality seemed impossible ten years ago: HIV infection is a chronic disease which, although incurable, is manageable lifelong with therapy, even in patients with resistant virus. CCR5 antagonists as well as integrase inhibitors have opened up new possibilities of treatment. It has become increasingly possible to lower viral loads to below detection in most patients. The pioneer drugs maraviroc and raltegravir have been shown to be extremely well-tolerated. These new drug classes will bring about fundamental changes to current ART. The dogma of always using two nucleoside analogs as the backbone of every therapy may start to change. Many of the currently widespread drugs will disappear over the next few years. The end of HIVID, Agenerase, Fortovase or Viracept is just the beginning. Veteran agents like AZT, d4T, ddI, nelfinavir or indinavir are not recommended by guidelines anymore although they served us in HIV management in the nineties. Will we be needing saquinavir, fosampranavir or even efavirenz and lopinavir as much as we do today five years from now? A normal life expectancy seems realistic today with treatment. This will pose a tremendous challenge for patients, physicians and for the pharmaceutical industry and payors. The comfortable situation at present does not mean one can relax. There is uncertainty about whether our drugs can stand the test of time over decades. Effects on the heart, kidney, bones and other organs in an aging HIV population are difficult to foresee. If the cure is delayed, over the decades one will need a wider breadth and range of available drugs. It will not be easy for new drugs to be approved, as vicriviroc has shown. How do you show the advantages of a new drug over other successful ther- apies today? Approval for new drugs is becoming more strict and the market is tight- ening. Already one can observe the pharmaceutical industry’s caution. The days may be over when an HIV drug got from the laboratory to the market within five years. Compared to the previous decade, the HIV ARV pipeline is now drying up. At the same time, the simple question of “when to start” with ART has remained unanswered for a long time. Instead of David Ho’s recommendation from the nineties “hit hard, hit early”, we often heared “hit HIV hard, but only when necessary” (Harrington 2000) during the last decade. With the START study results appearing at the horizon, there is no doubt that this will change again. What roles do the following play: viral load, CD4 T cell changes, CD4 percentages, age, gender, host elements and viral tropism?

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