A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

Hoffmann-La Roche40 enrolled

Overview

To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.

All enrolled patients will receive the following 3 drug combination: Saquinavir, Zidovudine and Lamivudine. Efficacy and duration of anti-viral response will be evaluated by monitoring of HIV-1 RNA levels. Patients below the detectable limit of 200 copies/ml will be analyzed using the Ultra-direct method with a detection limit of 20 copies/ml. CD4 and CD8 cell counts will also be analyzed.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

HIV Infections

Interventions

SaquinavirDRUG

LamivudineDRUG

ZidovudineDRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients must have: * Plasma HIV-1 RNA titers \> 10,000 copies/ml. * CD4 cell count \> 100 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with any of the following conditions will be excluded: * Any prior anti-retroviral drug therapy. Prior Medication: Excluded: Previous anti-retroviral drug therapy.

Locations (2)

AIDS Healthcare Foundation Labs

Los Angeles, California, United States

Urgent Care Ctr / North Broward Hosp District

Fort Lauderdale, Florida, United States

Data from ClinicalTrials.gov

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