A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients
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
2 other identifiers
interventional
230
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hiv-infections
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1999
CompletedFirst Submitted
Initial submission to the registry
April 6, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 2000
April 6, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (39)
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942050, United States
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712, United States
Longbeach Memorial Med Ctr
Longbeach, California, 90806, United States
Good Samaritan Hosp
Los Angeles, California, 90004, United States
THE Clinic
Los Angeles, California, 90008, United States
AIDS Healthcare Foundation
Los Angeles, California, 900276069, United States
Maxine Liggins
Los Angeles, California, 90042, United States
UCLA Care Ctr
Los Angeles, California, 90095, United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018, United States
San Francisco Gen Hosp
San Francisco, California, 94110, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Children's Diagnostic Treatment Ctr
Fort Lauderdale, Florida, 33301, United States
Community Health Care
Fort Lauderdale, Florida, 33306, United States
Comprehensive Care Center
Fort Lauderdale, Florida, 33316, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
South Shore Hosp
Miami, Florida, 33139, United States
Orange County Health Dept
Orlando, Florida, 32805, United States
Immunity Care and Research Inc
Plantation, Florida, 33324, United States
Daniel Seekins
Tampa, Florida, 33607, United States
Infectious Disease Research Institute
Tampa, Florida, 33614, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Ponce de Leon Ctr
Atlanta, Georgia, 30308, United States
Philip Brachman
Atlanta, Georgia, 30309, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Cook County Hosp
Chicago, Illinois, 60614, United States
HIV Outpatient Clinics / LA State Univ Med Ctr
New Orleans, Louisiana, 70112, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244, United States
WNC Community Health Services
Asheville, North Carolina, 28806, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28232, United States
Summa Health System
Akron, Ohio, 44304, United States
MCP Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102, United States
Miriam Hosp
Providence, Rhode Island, 02906, United States
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75235, United States
Thomas Street Clinic
Houston, Texas, 77009, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 782847881, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 6, 2000
First Posted
August 31, 2001
Study Start
September 1, 1999
Last Updated
June 24, 2005
Record last verified: 2000-11