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HIV Infections clinical trials

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NCT ID: NCT00248469 Completed - HIV Infections Clinical Trials

MEMA Kwa Vijana Trial: Impact of an Adolescent Sexual and Reproductive Health Intervention in Mwanza, Tanzania

Start date: July 1998
Phase: Phase 3
Study type: Interventional

The MEMA kwa Vijana Project is a community randomised trial which aims to assess the impact of a targeted intervention on adolescent sexual and reproductive health in Mwanza Region, Tanzania. The intervention aims to reduce HIV, STD and unwanted pregnancy amongst adolescents by improving reproductive health knowledge and by teaching skills to promote sexual behaviour change, and comprises community mobilisation, skills-based education in primary schools, and youth friendly health services. The evaluation includes a detailed process evaluation, and evaluation of the impact in a cohort of approx. 10,000 adolescents who will be followed for 3 years.

NCT ID: NCT00247845 Completed - HIV Infections Clinical Trials

Evaluation of Atazanavir Substitution Intervention (EASI) Study

Start date: July 2004
Phase: Phase 4
Study type: Observational

With the advent of highly active antiretroviral therapy (HAART), it was hypothesized that its consistent use could lead to a cure for HIV infection in as little as three years [Perelson, 1997]. Subsequent research has shown this model to be incorrect [Finzi, 1999]. In addition, long term use of HAART has now been associated with significant metabolic abnormalities, which could lead to unintended morbidity, possibly worse than what one could expect from the progression of untreated HIV-associated immune disease over the same period of time [Carr, 2000]. Accordingly, current recommendations for antiretroviral therapy have become more conservative. It is now suggested that a person with a CD4 count > 350 cells/mm³ may safely delay initiation of HAART [Yeni, 2002].However, for those who still require HAART, the risks of short-term and long-term toxicities remain, even if full virologic suppression is achieved. In this setting, a number of switching strategies have been evaluated (Negredo et al, 2002 & Martinez et al, 2003), mostly involving single drug substitutions of a protease inhibitor (PI) for a non-nucleoside agent (NNRTI) or abacavir (ABC). In general terms, these hae shown that virologic suppression is usually maintained, with improvement in drug-related side effects, including metabolic toxicities. A number of patients who are currently taking effective HAART are experiencing side effects to one or more of the agents in their regimen that is not severe enough to mandate an immediate change in their regimen, but that is having a measurable effect on their qualify of life. Over time, these effects may have an impact on adherence to therapy and its long-term efficacy. Given the recent availability of ATV (+/-RTV), its once daily administration, low pill count and favourable side effect profile, it is being used in clinical practice as part of single drug substitution strategies in patients exhibiting a maximal response to HAART. There is a clear need to examine this practice in a systematic manner to document its occurrence, efficacy and safety. We hypothesize that, in patients with maximal virologic suppression on a double class regimen (including two NRTIs and an NNRTI or a PI, boosted with RTV or not), and in whom a decision has been made to implement a single drug substitution of the NNRTI or PI for ATV (+/-), this will lead to an improvement in objectively measured quality of life without any negative impact on the virologic efficacy of the regimen.

NCT ID: NCT00246402 Completed - HIV Infections Clinical Trials

Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV

Start date: September 2002
Phase: N/A
Study type: Interventional

The purpose of this study is to test whether chronic administration of the drug acipimox will improve hyperlipidemia and insulin sensitivity among HIV infected patients experiencing highly active antiretroviral therapy (HAART) associated metabolic disturbances.

NCT ID: NCT00246376 Completed - HIV Infections Clinical Trials

Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia

Heart Positive
Start date: January 2004
Phase: N/A
Study type: Interventional

This study will evaluate the efficacy of diet and exercise (DE), with and without niacin and fenofibrate, in reducing the cardiovascular risk of patients with HIV lipodystrophy or dyslipidemia.

NCT ID: NCT00246363 Completed - HIV Infections Clinical Trials

A Clinical Research Study Designed To Determine If Treatment of Hepatitis C With Milk Thistle is More Effective Than No Treatment In Patients Infected With Both HIV And Hepatitis C

Start date: January 2005
Phase: Phase 1/Phase 2
Study type: Interventional

There is some information available that indicates that Milk Thistle is an effective treatment for liver disease. This study will compare Milk Thistle with a placebo, (a medicine that looks just like Milk Thistle but does not contain any Milk Thistle) to see if people with both Hepatitis C and HIV infections show improvement or cure of Hepatitis C. The study will last one year.

NCT ID: NCT00245531 Completed - Clinical trials for Human Immunodeficiency Virus Positive or Negative

Effects of Endocrine Health on Mental Performance of Men and Women Using Drugs

Start date: August 2004
Phase: N/A
Study type: Observational

The purpose of this study is to understand the effects of decreased functioning of the testes or ovaries on mental performance in males and females using illicit drugs excluding marijuana.

NCT ID: NCT00244803 Completed - Clinical trials for Human Immunodeficiency Virus

Redistribution of Fat and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)

Start date: January 2005
Phase: N/A
Study type: Observational

The purpose of this study is to learn whether HIV-infected patients have blood abnormalities which could lead to heart attack or stroke, and to find out what factors may contribute to these abnormalities.

NCT ID: NCT00243230 Completed - HIV Infections Clinical Trials

Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Participants (VICTOR-E1) (MK-7690-020/P03672)

VICTOR-E1
Start date: September 19, 2005
Phase: Phase 2
Study type: Interventional

Vicriviroc (vye-kri-VYE-rock) is an investigational drug that belongs to a new class of drugs, called C-C chemokine receptor type 5 (CCR5) receptor blockers. This group of drugs blocks one of the ways human immunodeficiency virus (HIV) enters T-cells (the cells that fight infection). The purpose of this 48-week study is to evaluate 2 dose levels of vicriviroc in participants with HIV who have not responded adequately to standard HIV treatments. This study was designed to evaluate the safety and efficacy of doses of vicriviroc, when taken in combination with other HIV drugs, in terms of ability to decrease the level of HIV (viral load) in the blood. The primary objective of the study was to evaluate antiviral efficacy of two doses of Vicriviroc maleate compared to placebo in combination with a protease inhibitor (PI)-containing optimized antiretroviral therapy (ART) regimen in CCR5-tropic HIV infected individuals failing a standard ART regimen.

NCT ID: NCT00243126 Completed - HIV Infections Clinical Trials

Family-based HIV Prevention for Adolescent Girls

Start date: November 2005
Phase: N/A
Study type: Interventional

This is an exploratory/developmental study to support the early phases of development and evaluation of a family-based HIV prevention program for adolescent girls prior to a full-scale trial. Research on the new intervention will include evaluating the feasibility, tolerability, and acceptability of the intervention, and allow us to obtain the preliminary data needed as a pre-requisite to a larger-scale intervention study. Adolescent females and their mother/guardian will be randomized to either: a family-based risk reduction intervention; or a no-treatment control group condition. Participants in both conditions will be assessed at baseline, immediate post-intervention, and at 3- and 6-month follow-ups. A subset of families (12 adolescents and 12 mothers) will participate in a qualitative interview following the 6-month follow-up, in which information will be obtained on participant perception of procedures and intervention content, and whether they have utilized skills taught following the end of the project.

NCT ID: NCT00242957 Completed - HIV Infections Clinical Trials

The Intervention With Microfinance for AIDS and Gender Equity (IMAGE) Study

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

The IMAGE Study is a cluster randomised trial of a structural intervention for the prevention of HIV and gender based violence being conducted in South Africa.