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HIV Infections clinical trials

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NCT ID: NCT00314626 Completed - HIV Infections Clinical Trials

Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily

Start date: November 2004
Phase: Phase 3
Study type: Interventional

To evaluate the proportion of patients with virological failure after 48 weeks of treatment with the combination of efavirenz 600 mg + lamivudine (3TC) 300 mg + abacavir 600 mg once daily as an antiretroviral simplification regimen.

NCT ID: NCT00312936 Completed - HIV Infections Clinical Trials

A Mindfulness Based Approach to HIV Treatment Side Effects

Start date: July 2006
Phase: Phase 1/Phase 2
Study type: Interventional

We are exploring the effect that an 8 week stress reduction program based in mindfulness practices will have on the experience of medication side effects reported by HIV-infected men and women taking antiretroviral therapy.

NCT ID: NCT00312923 Completed - HIV Infections Clinical Trials

Preliminary Study of Safety and Efficacy of Policosanol

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

Lay Language Summary: High cholesterol levels are common in persons with HIV infection. However, conventional cholesterol-lowering medications may have harmful side effects when given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of policosanol, a dietary supplement derived from sugar cane that has cholesterol-lowering properties, to lower cholesterol levels in persons with HIV infection. We hypothesize that policosanol will lower levels of LDL cholesterol ("bad" cholesterol) and raise levels of HDL cholesterol ("good" cholesterol).

NCT ID: NCT00312832 Completed - HIV Infections Clinical Trials

Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy

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

Background: Stavudine-containing regimens are associated with a potential for lipoatrophy and dyslipidemia. We assessed the safety and efficacy of reducing the dose of stavudine compared to switching to tenofovir or maintaining the standard dose of stavudine. Methods: Clinically stable lipoatrophic HIV-infected patients receiving antiretroviral therapy containing stavudine 40 mg bid with a plasma HIV RNA <200 copies/mL for at least 6 months were randomized to maintain stavudine 40 mg bid (d4T40 arm), to reduce to 30 mg bid (d4T30 arm), or to switch from stavudine to tenofovir-DF (TDF arm) while preserving the remaining drugs. Fasting metabolic parameters were assessed at baseline and at weeks 4, 12, and 24. Mitochondrial parameters in peripheral blood mononuclear cells and body composition were measured at baseline and at week 24.

NCT ID: NCT00312468 Completed - HIV Infections Clinical Trials

Examining the Link Between Heart Disease and HIV Infection in Women

Start date: October 2006
Phase:
Study type: Observational

Recent studies have shown that HIV infected individuals have an increased risk of developing heart disease, but the reason for this is not fully understood. This study will examine ultrasound test results of blood vessels and laboratory data of HIV infected and HIV uninfected women to examine the link between heart disease and HIV infection.

NCT ID: NCT00312169 Completed - HIV Infections Clinical Trials

Evolution of L74V or K65R Mutations in VIremic Subjects on Tenofovir Disoproxil Fumarate (TDF) or Abacavir (ABC) (EVITA)

Start date: April 2006
Phase: Phase 4
Study type: Observational

This is a multicenter, open-label, non-randomized, dual-arm pilot study to investigate the prevalence of the reverse transcriptase (RT) resistance mutations, K65R/x or L74V/x, in HIV-1 plasma from subjects experiencing confirmed first-time incomplete virologic suppression during treatment with an initial antiretroviral (ARV) regimen consisting of at least 12 weeks of TDF or ABC + emtricitabine (FTC) or lamivudine (3TC) + non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Subjects will be followed until a substantial loss of virologic or immunologic control requires a treatment switch. Confirmed first-time incomplete virologic suppression is defined as an initial plasma HIV-1 RNA response < 400 copies/mL, and subsequent virologic rebound > 400 copies/mL measured at two consecutive times. Subjects will have a screening genotype to establish adherence to their non-suppressive TDF- or ABC-containing regimen by the presence of M184V (or other treatment-related primary) mutation and to demonstrate that the evolution of treatment-emergent RT mutations can be characterized. Twenty subjects (a maximum of 10 per arm) will be enrolled at 10-20 United States (U.S.) sites. If fewer than 20 subjects can be enrolled, the study may be discontinued early by the sponsor. Equal numbers of subjects on Arm A versus Arm B will be a goal.

NCT ID: NCT00312091 Completed - HIV Infections Clinical Trials

Drug Levels of Tablet and Liquid Forms of Lamivudine, Nevirapine, and Stavudine in HIV Infected Thai Children

Start date: December 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to compare the blood levels, absorption, and breakdown of lamivudine (3TC), nevirapine (NVP), and stavudine (d4T) in a fixed-dose tablet to that of the individual liquid formulations of the same anti-HIV drugs in HIV infected Thai children.

NCT ID: NCT00312039 Completed - HIV Infections Clinical Trials

Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation

Resistance
Start date: March 31, 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Human immunodeficiency virus (HIV)-1 infected participants receiving long-term therapy with lamivudine or emtricitabine (nucleoside reverse transcriptase inhibitors [NRTIs]) are at risk for the development of a mutation at position M184 on the HIV reverse transcriptase gene. This mutation confers resistance to both drugs (>100 fold increase in the concentration of drug producing 50% inhibition [IC50]). In-vitro studies with elvucitabine have shown that HIV-1 isolates with the M184V mutation show only a 10-fold increase in IC50 as compared to wild type HIV-1. Alexion Pharmaceuticals Inc. intention is to demonstrate that 10 milligrams (mg) of elvucitabine, administered once per day for 14 days with continued background anti-HIV-1 medications, will demonstrate a fall in HIV-1 ribonucleic acid (RNA) plasma levels, as compared to baseline. The data from this study will guide dosing in future long-term studies in HIV-1 infected participants with the M184V mutation.

NCT ID: NCT00311688 Completed - HIV Infections Clinical Trials

Umbrella Study for HIV Infected Adults Enrolled in NIAID-Funded Interleukin-2 Studies

Start date: December 2003
Phase:
Study type: Observational [Patient Registry]

Interleukin-2 (IL-2) is a protein found naturally in the blood that helps boost the immune system. The purpose of this study is to provide long-term treatment and monitoring of HIV infected people enrolled in NIAID-funded studies investigating the use of laboratory-made IL-2 for the treatment of HIV infection.

NCT ID: NCT00310973 Completed - HIV Infections Clinical Trials

HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks

Start date: February 2003
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the effectiveness of peer-led HIV/sexually transmitted disease (STD)risk reduction educational counseling in reducing HIV risk behavior among the social networks of young men who have sex with men and Roma men and women in Bulgaria and Hungary.