View clinical trials related to HIV Infections.
Filter by:A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection.
Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.
Background: - The human immunodeficiency virus (HIV) causes acquired immune deficiency syndrome (AIDS). Combination antiretroviral therapy (ART) drugs treat HIV infection. They generally decrease the amount of HIV virus in the blood (called viral load) to very low levels. This happens only if the drugs still fight HIV and if taken every day exactly as prescribed. When not taken as directed, or if the ART drugs are not strong enough, the virus can become resistant to them, and the ART will not work to control the virus. Researchers want to know how to control HIV in people who can t lower their viral load with their current ART drugs. Objective: -<TAB>To better control HIV in people who can t get a lower viral load even with ART drugs and to learn more about why the HIV is not under control. Eligibility: - People at least 18 years old and with HIV. - People who have been on at least two combinations of ART drugs (including current ART). - People whose last two viral loads were greater than 1,000 copies/mL. Design: - Participants will be screened with medical history, physical exam, and blood tests. - Participants will then have a baseline visit. They will have another physical exam, blood tests, plus answer questions about what they know about HIV and ART, and how they take their ART. - Participants will arrange to stay in the NIH hospital for 7 8 days. - They will take their medications as usual. At the time to take the ART drugs, they will have to ask a nurse to bring them. If they forget, the nurse will bring them. - Participants will meet with a doctor, pharmacist, social worker and nurse to discuss ways to help participants remember to take their drugs. - Participants will have blood drawn about every other day. - Researchers will study the test results. Some participants will be put on different ART drugs. If that happens, participants will have another NIH hospital stay for 7-8 days. - Participants will have 4 follow-up visits over 12 weeks, then every 3 months for 2 years or more.
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA <50 copies/mL at Week 24. This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.
The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen. There are 2 parts to this study: Part 1 and Part 2. Part 1 consists of 2 cohorts, starting with a sentinel cohort, in which participants will be enrolled to receive open-label TAF in addition to their current failing ARV regimen. This cohort will then be followed by a randomized, double-blind, cohort to compare the addition of TAF or placebo in HIV-1 positive adults who are failing their current ARV regimen. In Part 2, all participants who complete Part 1 of the study will discontinue their failing ARV regimen and TAF or placebo for a 14-day washout period. Following the washout period, all participants who received TAF in Part 1 and have a > 0.5 log10 decline in HIV-1 RNA will receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) plus atazanavir (ATV) once daily for 48 weeks. Participants who received TAF who have a ≤ 0.5 log10 decline in HIV-1 RNA will be discontinued from the study and will not be eligible to continue into Part 2 of the study. All participants who received placebo in Part 1 will be eligible to participate in Part 2 regardless of their viral load change. After completion of Part 2, all participants will be eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF becomes commercially available, or until Gilead Sciences terminates development of E/C/F/TAF in the applicable country.
This study will be a phase I, open label, three period, fixed sequence crossover study to evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of Dolutegravir (DTG) and on the safety and tolerability of DTG. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There is no washout between treatment periods.
The potential HIV vaccine has two components: a protein immunogen based on the coat protein of HIV; and an adjuvant which enhances the vaccinee's response to the immunogen. The immunogen is CN54gp140, and the adjuvant is glucopyranosyl lipid adjuvant - aqueous formulation (GLA-AF). We wish to assess the vaccine's safety and immunogenicity (the nature of the immune response stimulated by the vaccine) when it is given in two different dose regimens: Group A: vaccinations at Months 0, 1, 2 and 6; and Group B: vaccinations at Months 0, 1, 2 and 12. Each dose will be an intramuscular injection of 100 micrograms of CN54gp140 mixed with 5 micrograms of GLA-AF. We will recruit only healthy, HIV-uninfected men and women. We will assess the safety of the vaccine by monitoring the occurrence of adverse events in the participants. We will assess the immunogenicity of the vaccine by monitoring the immune response to the vaccine in blood and in genital mucosal secretion samples.
It is estimated that over 1 million people in the United States have HIV infection. While HIV is treatable, there are still high rates of HIV-associated neurocognitive disorder (HAND). HAND is defined by low scores on memory testing. To meet the criteria for HAND, an HIV-infected individual has to have a low score on at least two different memory tests. It is estimated that 20-50% of people living with HIV have HAND. It is therefore still a common problem. While individuals with HAND typically improve on antiretroviral therapy for HIV, often this improvement is incomplete. Also, there are over 20 antiretroviral medications approved for HIV in the US. It is not clear if the specific choice of antiretroviral medication makes a difference in the improvement of HAND. The investigators have designed a small preliminary study in which subjects with and without HAND who have never been on treatment for HIV or have been off treatment for at least 6 months are followed for the first 12 months after starting antiretroviral therapy.The investigators will enroll a maximum of 46 subjects (23 subjects in each arm). Subjects will also be followed by their primary HIV medical provider. For the study, subjects will be followed for 48 weeks. There are three followup visits: 12 weeks, 24 weeks, and 48 weeks. Memory testing will be performed at baseline and each followup visit. Blood will also be taken at baseline and the three followup visits to measure changes in inflammation. A lumbar puncture will be performed at baseline and at 24 weeks to measure changes in inflammation and amount of HIV virus in the spinal fluid. There is also an optional lumbar puncture at the last study visit of 48 weeks
The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe
This protocol explores the feasibility and acceptability of using two daily diary methods to analyze state-dependent variables and psychosocial health outcomes in Human Immunodeficiency Virus (HIV)-positive young men who have sex with men (YMSM). The study will explore the potential of diaries for use in feedback-based interventions.