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HIV clinical trials

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NCT ID: NCT01906255 Completed - HIV Clinical Trials

Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)

Start date: October 7, 2013
Phase:
Study type: Observational

This is an observational study of HIV-1 negative individuals who participated in demonstration projects or clinical studies and took daily Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for pre-exposure prophylaxis (PrEP). All individuals were enrolled and followed as described in the parent PrEP demonstration project or clinical study protocol until study completion, HIV-1 infection, discontinuation due to an adverse event, lost to follow-up, or administrative censoring. In the protocols of the parent PrEP observational or clinical studies, participants had follow-up visits on average every 3 months for evaluation of adherence, renal and bone adverse events, and HIV-1 infection status. Adherence was determined by the specific FTC/TDF drug level measurement(s) outlined in the parent protocol. Gilead had collected data from 21 global PrEP demonstration projects and clinical studies for over 7,000 Truvada for PrEP users who had at least one measurement of adherence. Data from the different contributing studies were pooled for statistical analyses by Gilead.

NCT ID: NCT01903889 Completed - HIV Clinical Trials

Male Engagement in PMTCT Services

Start date: January 2013
Phase: N/A
Study type: Interventional

The study employs a quasi-experimental design in 8 public health centers in southwest Uganda offering care and treatment (C&T) services. In 4 health centers, a basic intervention is introduced, whereby HIV/AIDS providers are trained on contraception for HIV-positive women. They are charged with counseling C&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods. In the other 4 health centers, the basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services. This includes training of C&T providers on gender-based influences on health behaviors; provision of couples' HIV testing and FP counseling services; and community-based education for men to promote gender equitable norms and male participation in health services.

NCT ID: NCT01902693 Completed - Cancer Clinical Trials

Prospective HIV Chemotherapy Cohort Study

Start date: October 2013
Phase:
Study type: Observational

Human Immunodeficiency Virus (HIV) infection is very successfully treated with a type of therapy called Highly Active AntiRetroviral Therapy (HAART). Although HAART has made a great improvement to the health and lives of all people living with HIV, HAART cannot be stopped because it is not able to 'cure' or eliminate the HIV virus from all cells in the body - the remaining viruses are referred to as 'latent' or sleeping virus. As soon as the HAART treatment is stopped the virus comes back (wakes up). It is for this reason that stopping HAART treatment is not recommended. However, it may be that other drugs if given with HAART could have a stronger effect on the latent virus. There is some evidence from laboratory research that suggests that some of the drugs we use to treat certain types of cancer may have an effect on the latent virus. The purpose of this research study is to use new laboratory research technology to measure the amount of 'latent' virus in people who are treated with HAART who then need to use chemotherapy treatments for cancer. We will look at whether the levels of HIV virus are reduced in patients having chemotherapy by looking at the virus levels before, during and after chemotherapy treatment. We do not know very much about how HIV persists in the body despite therapy and unless new approaches are developed, removal of the HIV virus from all cells in the body will not be possible.

NCT ID: NCT01902472 Completed - HIV Clinical Trials

A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)

Start date: September 2, 2013
Phase:
Study type: Observational

This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assess the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and collect information regarding whether the seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the time of seroconversion.

NCT ID: NCT01901016 Completed - HIV Clinical Trials

Relaxation, Depressive Symptoms, Quality of Life in People Living With HIV: a Pilot Study

Start date: June 2013
Phase: N/A
Study type: Interventional

Progressive muscle relaxation (PMR) and autogenic training (AT) are effective relaxation techniques to reduce depressive symptoms. However, no studies on their effectiveness have been conducted among people living with HIV and depressive symptoms. The primary aim of this pilot study was to assess the feasibility and acceptability of PMR and AT interventions among people living with HIV who have depressive symptoms. A secondary aim was to assess the potential effectiveness of these interventions on depressive symptoms and quality of life.

NCT ID: NCT01900977 Completed - HIV Clinical Trials

Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART)

PopART
Start date: January 2014
Phase: N/A
Study type: Interventional

PopART is a community randomized trial that is investigating whether a community-wide combination HIV prevention package including annual home-based HIV testing, active referral and the offer of immediate ART for those testing HIV-positive, along with the promotion of proven HIV prevention methods (such as voluntary medical male circumcision, prevention of mother to child transmission and condom use), will help to prevent transmission and substantially reduce new HIV infections. The study is being conducted in 21 communities in Zambia and South Africa (randomized into 3 arms, each with 7 communities) with a total population of approximately 1.2 million individuals.

NCT ID: NCT01900236 Completed - HIV Clinical Trials

Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV

iENGAGE
Start date: December 2013
Phase: N/A
Study type: Interventional

iENGAGE is a 4 session, in-clinic behavioral intervention that is delivered to new clinic patients during the first year of HIV care on a flexible delivery schedule, with intervention visits scheduled to coincide with HIV medical care visits. Interventionists from each participating collaborating site will be trained centrally to implement the iENGAGE protocol. Following study enrollment and baseline assessment, participants will be randomized to treatment as usual and intervention groups. For intervention-arm participants, each iENGAGE intervention session includes: interventionist-delivered educational content for managing HIV medical care appointment-keeping and information sessions for learning to manage HIV medications. The intervention will have a tailored, interactive agenda for each of the 4 sessions based on behavioral motivational interviewing (MI) techniques. The goal of this intervention is for the participant to establish early behaviors that help him/her to arrive at scheduled medical appointments and learn to take medications as prescribed during the initial year of HIV care in order to improve overall health.

NCT ID: NCT01897909 Completed - HIV Clinical Trials

The Impact of Helicobacter Pylori Infection on Immune Regulation and Clinical Course in HIV Patients in Ghana

HHECO
Start date: November 2011
Phase:
Study type: Observational

The main objective of the study is to investigate the impact of H. pylori infection on immune activation and clinical outcome in HIV patients. Other specific study objectives are: 1. To investigate the effects of H. pylori infection on immune activation and the T-cell profile in HIV positive patients and compare those with HIV negative controls. 2. To assess the influence of H. pylori infection on virological and immune parameters, and on clinical progression of HIV infection (WHO stage, opportunistic infections). 3. To assess the prevalence of H. pylori infection among HIV patients in the Komfo Anokye Teaching Hospital. 4. To assess the prevalence of gastrointestinal symptoms in HIV patients in Kumasi. 5. To assess the association of H. pylori infection with gastrointestinal symptoms and pathology in HIV patients. 6. To compare the clinical and immunological response to antiretroviral therapy and in HIV-patients with and without concomitant H. pylori infection.

NCT ID: NCT01896921 Completed - HIV Clinical Trials

Switch to Maraviroc + Integrase Inhibitor

Start date: September 2013
Phase: Phase 3
Study type: Interventional

This clinical study proposes to evaluate the combination of maraviroc with an integrase strand transfer inhibitor (either raltegravir or dolutegravir) in antiretroviral-experienced patients to document the efficacy, safety, and tolerability of this combination in order to provide clinicians with a treatment regimen that minimizes the risk of metabolic complications by avoidance of NRTI/NNRTIs and PIs. The development of an alternative ART regimen which lessens the risk of metabolic complications could improve long-term adherence and reduce the risk of certain co-morbidities associated with long-term ART use. If this new combination is found to be as efficacious as the standard regimen with enhanced tolerability and improved metabolic effects, there is great potential for altering the current practice of HIV medicine.

NCT ID: NCT01896622 Completed - HIV Clinical Trials

The Interaction of Two HIV Medications With Blood Clot Medications in Healthy Volunteers

Start date: June 18, 2013
Phase: Phase 1
Study type: Interventional

Background: - People who have the human immunodeficiency virus (HIV) often take several medications to control their disease. They may also need to take medicine to prevent blood clots. Taking both kinds of medicine together can cause bleeding or other problems. But this might not happen if the medications are taken at different times. Researchers will study two particular HIV drugs (ritonavir and cobicistat) and how they interact with blood clot medications. Objectives: -To understand how HIV medicine and blood clot medicine interact, so doctors can choose what to prescribe for people who take both. Eligibility: - Healthy adults between 18 and 70 years old who are not on any medications. Design: - Participants will be screened with a physical exam and medical history. Blood samples will be collected. Urine samples will be collected from participants who might become pregnant. - Participants will visit the National Institutes of Health 7 times after the screening visit. Three visits will last about 12 hours. The other 4 will last about 1 hour. - Participants will take a daily dose of either study medication for 22 days. They will keep a diary of medicine they take and any side effects. - Treatment will be monitored with blood tests over about 2 months. - When the study of one drug is completed, the next drug study will begin with a different group of participants.