A Study of Two Anti-HIV Drug Combinations
A Randomized, Multicenter Study of Epivir 150 Mg Bid, Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 Mg/ZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients
2 other identifiers
interventional
N/A
2 countries
7
Brief Summary
The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs. Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.
Trial Health
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7 active sites
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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
CompletedJune 24, 2005
November 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- HIV infection documented by a licensed antibody ELISA assay and confirmed by Western blot, positive HIV blood culture, positive HIV serum antigen, or plasma viremia.
- CD4+ cell count of at least 300 cells/mm3.
- HIV-1 RNA less than 10,000 copies/ml by Roche Amplicor PCR assay.
- CDC Category A or B Classification for HIV infection (no clinical diagnosis of AIDS).
- Compliance with dosing schedule and protocol evaluations.
- Prior Medication:
- Required:
- TC at 150 mg bid, ZDV at 600 mg/day (200 mg tid or 300 mg bid), plus a marketed protease inhibitor (ritonavir, saquinavir, indinavir, or nelfinavir) at its recommended dose for at least 10 weeks.
- Allowed:
- Inhaled corticosteroids for the treatment of asthma.
You may not qualify if:
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Malabsorption syndromes affecting drug absorption (e.g., Crohn's disease and chronic pancreatitis).
- Enrollment in other investigational protocols.
- Concurrent Medication:
- Excluded:
- Cytotoxic chemotherapeutic agents.
- Nonnucleoside reverse transcriptase inhibitors.
- Other investigational agents.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Prior Medication:
- Excluded:
- Cytotoxic chemotherapeutic and immunomodulating agents such as systemic corticosteroids, IF-2, alpha-IFN, beta-IFN, or gamma-IFN (except for inhaled corticosteroids for the treatment of asthma) within 4 weeks of study entry.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (7)
Pacific Oaks Med Ctr
Beverly Hills, California, 90211, United States
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, 90048, United States
Univ of North Carolina Hosps
Chapel Hill, North Carolina, 27599, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28232, United States
Infectious Diseases Physicians Inc
Annandale, Virginia, 22003, United States
Univ of Wisconsin School of Medicine
Madison, Wisconsin, 53792, United States
San Juan AIDS Program
Santurce, 00907, Puerto Rico