A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml
2 other identifiers
interventional
200
2 countries
11
Brief Summary
To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
11 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
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 2, 2007
October 1, 2007
November 2, 1999
October 1, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- Documented HIV infection.
- CD4 cell count of 200 - 700 cells/mm3.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- AIDS defining condition within 1 month of study entry.
- Prior Medication:
- Excluded:
- Patients with any history of antiretroviral therapy treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
HIV Clinical Research Ctr
Fort Lauderdale, Florida, 33316, United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614, United States
Advance Clinical Research
Atlanta, Georgia, 30327, United States
Louisiana State Univ Med Ctr / HIV Outpatient Clinic
New Orleans, Louisiana, 70112, United States
Boston Univ Med Ctr Hosp / Evans - 556
Boston, Massachusetts, 02118, United States
Community Research Initiative of New England
Brookline, Massachusetts, 02445, United States
Washington Univ School of Medicine
St Louis, Missouri, 63108, United States
Blackstock Family Health Ctr
Austin, Texas, 76751, United States
Hosp Regional de Ponce - Area Vieja
Ponce, 00731, Puerto Rico
San Juan AIDS Program
Santurce, 00908, Puerto Rico