Home
Clinical Trials
NCT00005106

A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Drug Therapy, Combination Zidovudine Stavudine HIV Protease Inhibitors Lamivudine Nelfinavir Reverse Transcriptase Inhibitors Anti-HIV Agents Adipose Tissue Lipodystrophy abacavir

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lamivudine/Zidovudine

Intervention Type DRUG

Abacavir sulfate

Intervention Type DRUG

Nelfinavir mesylate

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old.
* Are HIV-positive.
* Have a CD4 count greater than 50 cells/mm3.
* Have a viral load greater than 1,000 copies/ml but less than 200,000 copies/ml.
* Have never received anti-HIV medications before. (However, less than 1 week of therapy with lamivudine or a protease inhibitor and less than 4 weeks of therapy with other nucleoside reverse transcriptase inhibitors \[NRTIs\] is allowed. No therapy with nonnucleoside reverse transcriptase inhibitors \[NNRTIs\] is allowed.)
* Cannot bear children or agree to use effective methods of birth control during the study. Hormonal methods of birth control (such as birth control pills) are not considered effective for this study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have an active AIDS-defining opportunistic infection or disease that, in the doctor's opinion, would make them unable to participate.
* Are unable, in the opinion of the doctor, to follow the dosing schedule and follow-up visit schedule.
* Have a substance abuse problem that would interfere with taking the medications correctly or attending the clinic visits.
* Are enrolled in another study.
* Cannot take medications by mouth or absorb drugs.
* Have hepatitis.
* Have a serious medical condition such as diabetes, congestive heart failure, or other heart disease.
* Need chemotherapy or radiation therapy (except for local treatment of Kaposi's sarcoma).
* Are taking certain medications.
* Are pregnant or breast-feeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Arizona Clinical Research Ctr Inc

Tucson, Arizona, United States

Site Status