View clinical trials related to HIV/AIDS.
Filter by:The primary objective of the proposed phase I trial is to evaluate the safety and tolerability of DNA-HIV-PT123 and AIDSVAX®B/E combination regimen. Though both DNA-HIV-PT123 and AIDSVAX®B/E and the combination of the two vaccines have been evaluated in humans and have shown to be safe and well tolerated, this is the first time the combination regimen is being evaluated in HIV-1 uninfected African populations with and without S. mansoni. The secondary objective of the trial is to evaluate the effect of S. mansoni infection on the immunogenicity of the combination of DNA-HIV-PT123 and AIDSVAX® B/E vaccine regimen. Successful vaccination against most viruses requires efficient Th1 response. There is evidence that helminth infections skew the host immune system of human and animals to T-helper type 2 (Th2) and induce immunosuppression. Therefore, there is a potential that helminth infected populations may not generate the desired immune responses to vaccines designed to drive Th1-type and cytotoxic T-cell responses. Furthermore, the influence of helminth infections on the development of protective antibody responses remains unclear. Limited data in animal models suggests that worm infections reduced efficacy of vaccines. The proposed vaccine trial will generate safety, tolerability and immunogenicity data of a vaccination regimen with simultaneous administration of a candidate HIV DNA vaccine (DNA-HIV-PT123) and a gp120 protein vaccine (AIDSVAX®B/E). This will be the first HIV vaccine trial to prospectively evaluate the impact of the S. mansoni infection on safety and immune responses to HIV vaccines.
The purpose of the study is to evaluate the safety, acceptability, and PK/PD profile of maraviroc gel following rectal and vaginal administration. The study also includes oral exposure to maraviroc.
Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL), prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits communities by reducing transmission to others. Mere availability of ART and care, however, is insufficient; the benefits of ART depend upon HIV+ persons' continuous visits to the health care provider, regular monitoring and regular delivery of medications, - known as retention in HIV care. In spite of national efforts, up to a quarter of HIV+ persons, especially low-income minorities are out of care. Innovative interventions are therefore urgently needed to maximize engagement and retention in HIV care, self-reported adherence, as well as HIV-1 RNA viral load suppression. In pursuit of these aims, the proposed study will assess outcomes of the following interventions in comparison to usual care: 1) contingency management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach that integrates both CM and PN (CA) which the investigators hypothesize to be most effective in improving HIV clinical outcomes.
This randomized clinical trial is testing if telephone-administered interpersonal psychotherapy (IPT) can reduce depression in rural persons living with HIV/AIDS.
Clinical social workers, doctors, outreach workers, and all other staff providing direct care to vulnerable populations face multiple challenges in obtaining and maintaining training and implementing evidence based practices in diverse community settings. Motivational Interviewing is a well-established evidence based practice that is challenging to implement across programs and agencies because it requires that skills gained from training be reinforced as a service provider employs the practice. This study builds on findings from a Phase I study. With funding from a Phase I Small Business Innovation Research grant from the National Institute of Health, the Center for Social Innovation developed the Motivational Interviewing Simulator: An Experiential Online Training Tool. The interactive, case-based, multiplayer web-based game allows service providers to deepen their skills in Motivational Interviewing (MI), a widely recognized evidence-based practice that supports people to make positive behavior changes related to health, wellness, mental illness, and addiction. The Phase II randomized controlled trial's primary aim is to assess the relative effectiveness of three interventions (MI Training Only; MI Training + eBook; MI Training + SIM) in increasing provider MI knowledge and skill retention over time. During Phase II of this study, we will recruit 180 providers from 18 community agencies serving individuals who live in supportive housing, many of whom have histories of mental illness, addiction, homelessness, and medical problems. After receiving a standardized two-day onsite MI training, participants will be randomized into one of three conditions: 1) MI Training Only; 2) MI Training + eBook (an online comparison with comparable information to the Simulator without the interactive elements); or 3) MI Training + Simulator. The longitudinal, mixed methods study will assess providers' acquisition and retention of MI knowledge and skills through surveys and coding of standardized client interviews; barriers and facilitators of MI implementation via focus groups; organizational-level data via key informant interviews and site visits; and client outcomes for 3,600 clients through surveys, administrative, data and focus groups.
Background: - Cervical cancer is a major cause of cancer deaths among women. Most cases of cervical cancer are caused by the human papillomavirus (HPV). HPV is more common in women who have the human immunodeficiency virus (HIV). India has one of the highest rates of women who have both cervical cancer and HIV infection. - Cervical cancer can be discovered in early stages by screening for HPV infection. Researchers want to compare new cervical cancer screening tests for HIV-infected women. They also want to know more about how HPV can lead to cervical cancer in HIV-infected women. To do so, they will hold a study to screen HIV-infected women in India. Objectives: - To improve cervical cancer screening methods in HIV-infected women in India. Eligibility: - Women at least 18 years of age who have HIV infection. - Participants will be recruited from HIV-focused health care clinics in Pune and Chennai, India. Design: - Participants will have a physical exam and medical history. They will provide a urine sample and proof of HIV infection. - Participants will have a gynecological exam. This will involve a pelvic exam and Pap smear to collect cells for study. It will also involve a cervical exam to look for precancerous cells. Cervical tissue may be collected. - Participants will also provide a blood sample for testing. - Participants will return in 2 weeks for the test results. If there are signs of precancerous or cancer cells, participants will be referred to a doctor for treatment.
The investigators will pilot test the intervention by randomizing 30 couples to one of three conditions: 1) DuoPACT, the newly-developed couples intervention; 2) Life Steps, a standardized antiretroviral adherence intervention for HIV+ individuals; and 3) a treatment as usual (TAU) assessment-only control condition. After randomization, intervention sessions will be delivered weekly (6 DuoPACT sessions, or 3 Life Steps sessions). All couples will be assessed pre/post intervention to evaluate intervention acceptability and feasibility.
Black men who have sex with men (MSM) have among the highest rates of new HIV infections of any group in the United States. Developing effective HIV prevention interventions that work with this group is a critical element of the National HIV/AIDS Strategy. In the first phase of our study ("the ethnographic phase"), the investigators will carry out community-based research that will explore structural, social and cultural factors relevant to how Black MSM might engage with Pre-Exposure Prophylaxis (PrEP). This phase of community-based research will inform the design of an enhanced PrEP adherence intervention, which will be subsequently tested at a community-based health clinic in Harlem in the second phase of the project.
The purpose of this study is to determine whether multiple doses of Efavirenz has an effect on the QTc interval (corrected by Fridericia) in CYP2B6 *1/*6 and *6/*6 healthy subjects.
The aim of this pilot study is to assess the feasibility, efficacy and safety of Darunavir/ritonavir 800/100 mg once daily (DRV/r) monotherapy as a switch-maintenance strategy for patients receiving second-line ART at Yaoundé Central Hospital in Cameroon. HIV-infected adults receiving second-line antiretroviral therapy (ART) for ≥3 months with 2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus either lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) will undergo plasma HIV-1 RNA ("viral") load testing. Those with a viral load below 50 copies/ml (<50 cps/ml) will undergo a repeat test ideally 4-6 weeks later (allowed up to 12 weeks); if the viral load is confirmed as <50 cps/ml the patient will be invited to join the randomised phase of the study. Patients (n=150) will be randomised 1:2 to either continue the current triple ART regimen (n=50) or switch to DRV/r monotherapy (n=100). The primary end-point will be viral load suppression <400 cps/ml at week 24; secondary end-points will be viral load suppression <50 cps/ml at week 12 and week 24, safety, tolerability, and emergence of protease inhibitor (PI) drug-resistance. Patients will continue observational follow-up depending on the treatment arm they are randomized to. After week 48, patients will return to local standard of care. Pharmacokinetics (PK) and pharmacogenomics sub-study to correlate plasma concentrations of DRV to outcomes, HIV-1 drug resistance testing sub study to detect mutants archived at the time of first-line ART failure and measuring HIV DNA load will be performed, as well as a cost-effectiveness analysis will test the hypothesis that savings can be achieved by switching to DRV/r monotherapy without affecting quality of care. The primary virological objective is to evaluate efficacy in terms of the percentage of subjects who have plasma HIV-1 RNA levels <400 cps/ml after 24 weeks of follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing 2 NRTIs + LPV/r (or ATV/r) (FDA Snapshot method). Study hypothesis: we propose that maintenance therapy with DRV/r monotherapy is a feasible, effective and safe treatment option for patients receiving second-line ART in Yaoundé.