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

June 23, 2005 updated by: Glaxo Wellcome

A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250mg BID) Versus Abacavir (300mg BID) Plus Combivir (3TC 150mg/ZDV 300mg BID) Versus Combivir (3TC 150mg/ZDV 300mg BID) Plus Nelfinavir (1250mg BID) in HIV-1 Infected Subjects

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 352942050
        • Univ of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Ctr Inc
    • California
      • Longbeach, California, United States, 90806
        • Longbeach Memorial Med Ctr
      • Los Angeles, California, United States, 90095
        • UCLA CARE Ctr
      • Los Angeles, California, United States, 90004
        • Good Samaritan Hosp
      • Los Angeles, California, United States, 90008
        • The Clinic
      • Los Angeles, California, United States, 900276069
        • Aids Healthcare Foundation
      • Los Angeles, California, United States, 90042
        • Maxine Liggins
      • Oakland, California, United States, 946021018
        • Highland Gen Hosp / San Francisco Gen Hosp
      • San Francisco, California, United States, 94110
        • San Francisco Gen Hosp
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • IDC Research Initiative
      • Fort Lauderdale, Florida, United States, 33301
        • Children's Diagnostic Treatment Ctr
      • Fort Lauderdale, Florida, United States, 33306
        • Community Health care
      • Fort Lauderdale, Florida, United States, 33316
        • Comprehensive Care Center
      • Miami, Florida, United States, 33136
        • Univ of Miami School of Medicine
      • Miami, Florida, United States, 33139
        • South Shore Hosp
      • Orlando, Florida, United States, 32805
        • Orange County Health Dept
      • Plantation, Florida, United States, 33324
        • Immunity Care and Research Inc
      • Tampa, Florida, United States, 33607
        • Daniel Seekins
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
      • Atlanta, Georgia, United States, 30308
        • Ponce de Leon Ctr
      • Atlanta, Georgia, United States, 30309
        • Philip Brachman
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
      • Chicago, Illinois, United States, 60614
        • Cook County Hosp
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • HIV Outpatient Clinics / LA State Univ Med Ctr
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med Ctr
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Univ of Missouri at Kansas City School of Medicine
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
        • South Jersey Infectious Diseases Inc
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • WNC Community Health Services
      • Charlotte, North Carolina, United States, 28232
        • Carolinas Med Ctr
    • Ohio
      • Akron, Ohio, United States, 44304
        • Summa Health System
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • MCP Hahnemann Univ Hosp
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hosp
    • Texas
      • Dallas, Texas, United States, 75235
        • Univ of Texas Southwestern Med Ctr
      • Houston, Texas, United States, 77009
        • Thomas Street Clinic
      • San Antonio, Texas, United States, 782847881
        • Univ TX San Antonio Health Science Ctr
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Hampton Roads Med Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glaxo Wellcome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 1999

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2000

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 264P
  • ESS40002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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