A Study of Two Anti-HIV Drug Combinations
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, CD4-CD8 Ratio, Lamivudine, Patient Compliance, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
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.
Sites / Locations
- Pacific Oaks Med Ctr
- Tower Infectious Diseases / Med Associates Inc
- Univ of North Carolina Hosps
- Carolinas Med Ctr
- Infectious Diseases Physicians Inc
- Univ of Wisconsin School of Medicine
- San Juan AIDS Program