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HIV Infections clinical trials

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NCT ID: NCT00245739 Approved for marketing - HIV Infections Clinical Trials

TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.

Start date: n/a
Phase: Phase 3
Study type: Expanded Access

The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients with limited or no treatment options, who have failed multiple antiretroviral (ARV) regimens, and to evaluate the longer-term safety and tolerability of TMC114/r in combination with other antiretrovirals

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NCT ID: NCT00243568 Withdrawn - HIV Infections Clinical Trials

Vicriviroc, a CCR5 Inhibitor, Added to an Optimized Antiretroviral Therapy for Previously Treated HIV (VICTOR-E2) (Study P04285

Start date: September 1, 2005
Phase: Phase 3
Study type: Interventional

This is an international study of vicriviroc in 500 adult HIV-infected subjects who are failing standard antiretroviral therapy (ART). HIV must be of a certain type known as R5/X4-mixed tropic. Subjects allowed into the trial will be randomly assigned to treatment with vicriviroc 10 mg QD, vicriviroc 15 mg QD, or placebo in addition to other antiretrovirals (selected by the investigator to be optimal for the specific subject) containing at least 3 drugs, including a protease inhibitor (PI) boosted with at least 100 mg ritonavir QD. Subjects will be continued for up to 48 weeks of dosing.

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.

NCT ID: NCT00242879 Terminated - HIV-1 Infection Clinical Trials

A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults

Start date: August 2005
Phase: Phase 2
Study type: Interventional

This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.

NCT ID: NCT00242840 Completed - HIV Infection Clinical Trials

Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)

Start date: June 2003
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.

NCT ID: NCT00242216 Completed - HIV Infections Clinical Trials

"The Once A Day Protease Inhibitor Regimens"

Start date: May 2004
Phase: Phase 4
Study type: Interventional

Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors that can be administered once-a-day and boosted with ritonavir (r). Prior studies have demonstrated that both are effective in treatment of ARV-naïve HIV-infected people. This study was designed to demonstrate if a HAART regimen containing ATV/r is not inferior to a HAART regimen containing fAPV/r, in ARV-naïve patients over a 96-week period. This is a phase IV, single center, randomized, open label, 2-arm clinical trial in ARV therapy-naïve patients with HIV-1 RNA >1,000 copes/mL and CD4 cell count <350 cells/mm3. Patients will be randomized to receive tenofovir and emtricitabine plus either ATV (300mg qd) and ritonavir (100mg qd) or fAPV (1400mg qd) and ritonavir (200mg qd).