HIV Infections
Conditions
Keywords
Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, CD4-CD8 Ratio, Lamivudine, Patient Compliance, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
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.
Detailed description
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.
Interventions
DRUGLamivudine/Zidovudine
DRUGLamivudine
DRUGZidovudine
Sponsors
Glaxo Wellcome
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
Puerto Rico, United States
Outcome results
None listed