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HIV/AIDS clinical trials

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NCT ID: NCT00958100 Completed - HIV Infections Clinical Trials

Raltegravir Switch for Toxicity or Adverse Events

RaSTA
Start date: August 2009
Phase: Phase 2
Study type: Interventional

This study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues or adverse events.

NCT ID: NCT00855088 Completed - HIV Infections Clinical Trials

Study in Healthy Males to Measure Darunavir and Etravirine in Blood, Seminal Fluid, and Rectal Tissue

DESeRT
Start date: July 2009
Phase: Phase 1
Study type: Interventional

This study is being conducted to look at how the body handles the drugs darunavir and etravirine. It will measure the amount of darunavir and etravirine in blood, semen, and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.

NCT ID: NCT00829114 Completed - HIV Infections Clinical Trials

Interactions Between Antiretrovirals (ARVs) and Combined Oral Contraceptives (COCs)

Start date: March 2009
Phase: Phase 4
Study type: Interventional

Non-randomized, comparative study (1:1 allocation) to study interactions between nevirapine-containing antiretroviral therapies and combined oral contraceptive pills.

NCT ID: NCT00821366 Active, not recruiting - HIV Infections Clinical Trials

Effective Aids Treatment and Support in the Free State (FEATS)

FEATS
Start date: October 2007
Phase: Phase 3
Study type: Interventional

The aim of this study is to investigate the benefits of ARV treatment to patients, to the family members of patients on ARV treatment, and to communities at large. The study also aims to investigate the impact of a peer adherence support and a nutritional intervention on measures of treatment success. To this end, 648 patients who had commenced ARV treatment in the past month at twelve selected health care facilities will be recruited into the study. In addition, 204 randomly sampled households from the communities served by the twelve selected clinics will be recruited into the study. Trained enumerators will at baseline conduct semi-structured interviews with patients and households. Following the baseline survey, patients recruited into the study will be randomly assigned to one of three groups: - Patients receiving ARV treatment and the associated support currently provided in the public sector ARV treatment programme. - Patients receiving (a) plus bi-weekly visits by an experienced ARV patient who has been trained as a peer adherence supporter - Patients receiving (a) and (b) plus a weekly nutritional supplement in the form of two 400g cans of meatballs and spaghetti in tomato sauce The group of 'comparison' households comprises the fourth group. Trained enumerators will conduct follow-up interviews with all patients and households at approximately six- and at twelve-months respectively. In addition, the ARV coordinator and other providers working in the ARV treatment programme at each of the twelve selected health care facilities will be interviewed by trained enumerators, at baseline and again at six- and at twelve-months. Clinical data will be obtained from patient files at baseline and at completion of the study. Using these data, various outcomes of importance to the study will be compared between the four study groups, using experimental and non-experimental methods.

NCT ID: NCT00786396 Completed - HIV/AIDS Clinical Trials

Directly Observed Therapy for Community-Released HIV+ Prisoners

Connect
Start date: July 2004
Phase: N/A
Study type: Interventional

The aim of this study is to develop effective interventions for HIV-infected prisoners who are released to the community. The intervention that we will study will be directly observed therapy (DAART/DOT) and we will compare this to the current standard of care that involves self-administered therapy (SAT). All subjects will get transitional case management and all subjects with a prior history of opiate dependence will be offered opiate substitution therapy (buprenorphine or methadone). Hypotheses: - At the end of six months those receiving DAART will have a higher level of adherence to HAART as compared to the SAT group. - The DAART Intervention will result in subjects having lower viral loads and higher CD4 counts as compared to the SAT group. - At the end of six months, the DAART group will have a lower rate of recidivism to jail/prison as compared to the SAT group. - Over the year, the DAART group will be more likely to make repeated primary HIV care visits than the SAT group.

NCT ID: NCT00775294 Completed - HIV/AIDS Clinical Trials

Study in Healthy Males to Measure Maraviroc in Blood, Saliva, Seminal Fluid, and Rectal Tissue

Start date: May 2008
Phase: Phase 1
Study type: Interventional

This study is being conducted to look at how the body handles the drug maraviroc. It will measure the amount of maraviroc in blood, semen, saliva and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the oral, reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, saliva, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.

NCT ID: NCT00722644 Completed - HIV/AIDS Clinical Trials

Cognitive Behavioral Stress Management for HIV+ Drug Abusers

Start date: September 1999
Phase: Phase 1
Study type: Interventional

The primary purpose of this 5-year study is to determine whether a Cognitive Behavioral Stress Management (CBSM) intervention, demonstrated to be effective in reducing distress, enhancing coping, and maintaining health among HIV+ non-drug abusers (see Schneiderman and Antoni, 2000), can be effectively adapted for our target population of culturally diverse, HIV+, low-income "Recovering Drug Abusers" (RDAs). Since the late 1980s, members of our research team (i.e., Schneiderman, Antoni, Klimas, Fletcher) have been developing, refining and evaluating the effects of CBSM among HIV+ Men who have Sex with Men (MSM). In the early/mid 90s, we began to adapt and evaluate the effects of CBSM in other non-drug abusing subgroups that were emerging with increasing levels of HIV seroprevalence (e.g., pregnant women, African American and Hispanic men and women). After accumulating considerable support for the effectiveness of CBSM in these subgroups in the late 90s, our research team (i.e., Malow, Schneiderman, Antoni, Klimas, Page) turned its attention to developing the CBSM for one of the most neglected and understudied populations affected by the HIV/AIDS epidemic in this country: "inner city" minority drug abusers. With supplemental funding on two NIH grants to conduct formative stage1 pilot research, our project team has been able to develop and document the feasibility and potential promise of the CBSM approach adapted/translated for RDAs (CBSM-RDA). This application proposes to take the next logical step in continuing this work: conducting a 3, 6, 8, 10, and 12 month follow-up outcome study comparing CBSM-RDA with a matched attention, time and interest value Health Promotion Comparison (HPC) condition, in 225 male and 225 female HIV+ RDAs with respect to key biopsychosocial health endpoints: distress (i.e., depressive symptoms, and mood state), quality of life, drug abuse relapse, unsafe sex, Combination Antiretroviral Therapy (CART) medication adherence and health status indicators (e.g., Viral Load, CD4 count, physical symptoms).

NCT ID: NCT00367172 Completed - HIV/AIDS Clinical Trials

Directly Observed Antiretroviral Therapy Among Active Drug Users

Start date: June 2001
Phase: N/A
Study type: Interventional

The goal of this randomized, controlled trial is to compare the effectiveness of a community-based program of providing supervised antiretroviral therapy to HIV-positive drug users, compared to having the patients take the medicines on their own.

NCT ID: NCT00356291 Completed - HIV/AIDS Clinical Trials

Improving HIV Prevention Skills in People With Serious Mental Illnesses

Start date: April 2007
Phase: Phase 2
Study type: Interventional

This study will evaluate the effectiveness of motivational interviewing plus skill building in reducing HIV risk behavior in people with serious mental illnesses.