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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lamivudine/Zidovudine
Abacavir sulfate
Nelfinavir mesylate
Lamivudine
Stavudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Adipose Tissue, Lipodystrophy, abacavir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Arizona Clinical Research Ctr Inc
  • Longbeach Memorial Med Ctr
  • Good Samaritan Hosp
  • THE Clinic
  • AIDS Healthcare Foundation
  • Maxine Liggins
  • UCLA Care Ctr
  • Highland Gen Hosp / San Francisco Gen Hosp
  • San Francisco Gen Hosp
  • Georgetown Univ Med Ctr
  • IDC Research Initiative
  • Children's Diagnostic Treatment Ctr
  • Community Health Care
  • Comprehensive Care Center
  • Univ of Miami School of Medicine
  • South Shore Hosp
  • Orange County Health Dept
  • Immunity Care and Research Inc
  • Daniel Seekins
  • Infectious Disease Research Institute
  • AIDS Research Consortium of Atlanta
  • Ponce de Leon Ctr
  • Philip Brachman
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Cook County Hosp
  • HIV Outpatient Clinics / LA State Univ Med Ctr
  • Beth Israel Deaconess Med Ctr
  • Univ of Missouri at Kansas City School of Medicine
  • South Jersey Infectious Diseases Inc
  • WNC Community Health Services
  • Carolinas Med Ctr
  • Summa Health System
  • MCP Hahnemann Univ Hosp
  • Miriam Hosp
  • Univ of Texas Southwestern Med Ctr
  • Thomas Street Clinic
  • Univ TX San Antonio Health Science Ctr
  • Hampton Roads Med Specialists

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00005106
Brief Title
A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2000
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Adipose Tissue, Lipodystrophy, abacavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Enrollment
230 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamivudine/Zidovudine
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
352942050
Country
United States
Facility Name
Arizona Clinical Research Ctr Inc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Longbeach Memorial Med Ctr
City
Longbeach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Good Samaritan Hosp
City
Los Angeles
State/Province
California
ZIP/Postal Code
90004
Country
United States
Facility Name
THE Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90008
Country
United States
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
900276069
Country
United States
Facility Name
Maxine Liggins
City
Los Angeles
State/Province
California
ZIP/Postal Code
90042
Country
United States
Facility Name
UCLA Care Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Highland Gen Hosp / San Francisco Gen Hosp
City
Oakland
State/Province
California
ZIP/Postal Code
946021018
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Children's Diagnostic Treatment Ctr
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
Facility Name
Community Health Care
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Comprehensive Care Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
South Shore Hosp
City
Miami
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
Orange County Health Dept
City
Orlando
State/Province
Florida
ZIP/Postal Code
32805
Country
United States
Facility Name
Immunity Care and Research Inc
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Daniel Seekins
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Infectious Disease Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Ponce de Leon Ctr
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Philip Brachman
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
HIV Outpatient Clinics / LA State Univ Med Ctr
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Beth Israel Deaconess Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Univ of Missouri at Kansas City School of Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
South Jersey Infectious Diseases Inc
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
WNC Community Health Services
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Carolinas Med Ctr
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
MCP Hahnemann Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Miriam Hosp
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Univ TX San Antonio Health Science Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
782847881
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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