A Study of Two Anti-HIV Drug Combinations

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: HIV Protease Inhibitors; Lamivudine; Lamivudine, zidovudine drug combination; Protease Inhibitors; Zidovudine

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.