Active clinical trials for "HIV Infections"

The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release [IR]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.

The purpose of this study is to evaluate whether a therapy with an all once daily regimen of efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.

Objectives Primary To investigate the possibility of maintaining virological suppression of HIV in infected patients, switching them to LPV/r as the only antiretroviral agent To assess the immunological response in patients who switched to LPV/r as single agent, based on the observation of changes in the serum levels of CD4+ cells. Secondary To investigate the rate of clinical and laboratorial adverse events in the two treatment groups. To investigate the rate of emergence of antiretroviral resistance mutations in the two treatment groups, in case of virological failure of the current regimen. To describe the adherence to the prescribed regimen in the two treatment groups To describe changes in body fat distribution (abdominal, arms and thigh circumference) and in the lipid profile, in patients from the two treatment groups To describe the rate of clinical failure of the antiretroviral therapy in the two treatment groups. Patient population: The 60 patients were selected by the investigators according to the study's inclusion and exclusion criteria, and were divided into 2 groups with 30 patients each. Study design: The study is multicentric, open-label, randomized. Virological, immunological and clinical failures will be analyzed in both groups. In addition, data on clinical or laboratorial toxicity and compliance are being recorded. Regime: Group 1 maintenance of the currently used antiretroviral therapy Group 2 switch to LPV/r antiretroviral monotherapy in the dose of 400/100 mg 12/12 hs with food. Patients in group 2 who were being treated previously with non-nucleoside reverse transcriptase inhibitors (Efavirenz or Nevirapine) were instructed to take 4 capsules of Lopinavir/r each 12 hs, during the first 14 days of therapy (up to Week 2 visit). Duration: 96 weeks of treatment

The primary purpose of the study is to assess the safety and pharmacokinetics of KP-1461 given every 12 hours for 14 days when administered to HIV+ patients who have failed multiple highly active antiretroviral therapy (HAART) regimens. Patients currently on HAART will be required to discontinue all HAART medications for up to 6 weeks after screening eligibility has been determined.

This study will test the safety and side effects of an experimental vaccine booster against HIV. A vaccine is a substance given to try to create immunity or resistance to a disease or infection. The vaccine used in this study is called VRC-HIVADV014-00-VP. It is made from an adenovirus (a common virus that causes upper respiratory infections) that contains DNA (genetic material) of three HIV proteins. Injected into a human, the viral DNA instructs the body to make small amounts of some HIV proteins. VRC-HIVADV014-00-VP will be given to people who previously received a vaccine called VRC-HIVDNA009-00-VP under NIH protocol 03-I-0022. Important: Study participants cannot catch an adenovirus infection or HIV or AIDS from the vaccine or any proteins made from it. Healthy normal volunteers who participated in NIH protocol 03-I-0022 may be eligible for this study. They must have completed three injections of 4 mg or 8 mg of VRC-HIVDNA009-00-VP without experiencing a serious side effect that was possibly related to the vaccine. Candidates are screened with a medical history, clinical evaluation, blood and urine tests, and HIV and pregnancy counseling. Participants receive one injection of VRC-HIVADV014-00-VP the day they enroll in the study (study day 0). They are observed for at least 30 minutes after immunization. At home, they record their temperature and any symptoms they may experience, including any effects at the injection site, for 5 days and call a study nurse 1 or 2 days after the injection. They immediately report any symptoms to the clinic staff and, if necessary, come to the clinic for an examination. Participants have five additional clinic visits during the study, at weeks 2, 4, 6, 12 and 24, each lasting about 2 hours. At each visit, they are checked for health changes or problems and are asked about medications they are taking. Blood is drawn for immune function testing, HLA typing (a genetic test of immune system markers), and other genetic factors. A urine sample is collected at some visits. Additional laboratory tests may be requested between visits. Some participants may undergo apheresis at the week 4 visit to collect a large number of white blood cells for laboratory tests to see how the immune system responds to the study vaccine. For this procedure, blood is collected through a needle in an arm vein and flows through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The white cells are extracted and the rest of the blood is returned through another needle in the other arm. The procedure takes about 1 to 3 hours. Participants are tested three or more times for HIV and are questioned about their sexual behavior and drug use. They complete a "social impact" questionnaire at week 24 that includes questions about any problems they may have experienced from their participation in the study regarding such things as insurance, health care, friends, family, employment, housing, education, or government agencies.

The purpose of this study is to see if cyclosporine, taken when a patient begins highly active antiretroviral therapy (HAART), increases the number of CD4 T-cells (blood cells that fight infection) in a patient's blood. This study also will explore the safety of briefly giving cyclosporine to patients starting HAART.

The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied.

The purpose of this study is to compare the safety and effectiveness of 9 doses of HU in order to find the best dose of HU to use with ddI and d4T in fighting HIV infection. HU plus ddI plus d4T appears to be a suitable anti-HIV drug combination for long-term control of HIV. This combination can sharply decrease viral load (level of HIV in the body) with few side effects, making it easy to take.

To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT. PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.

The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV drugs. This study also examines how the body processes these drugs when they are given together.