A Study of Two Anti-HIV Drug Combinations

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

ClinConnect Summary

It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor.

Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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:
• • 3TC 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.
• • Exclusion Criteria
• 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.
• • HIV immunotherapeutic vaccine within 3 months of study entry.
• Prior Treatment:
• Excluded:
• • Radiation therapy within 4 weeks of study entry.