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Home > "A" Clinical Trials Conditions > A Study of Two Anti-HIV Drug Combinations  A Study of Two Anti-HIV Drug Combinations
A Study of Two Anti-HIV Drug Combinations
For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
San Juan AIDS Program
Santurce, , 00907
Puerto Rico
Univ of Wisconsin School of Medicine
Madison, Wisconsin, 53792
United States
Pacific Oaks Med Ctr
Beverly Hills, California, 90211
United States
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, 90048
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28232
United States
Infectious Diseases Physicians Inc
Annandale, Virginia, 22003
United States
Univ of North Carolina Hosps
Chapel Hill, North Carolina, 27599
United States
Additional Information:
Study ID Numbers: 280A; NZTA4001
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002203
Other Hiv Infections Studies:
1. A Study of Stem Cells and Filgrastim
2. Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
3. A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients
4. Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
5. Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated with Zidovudine
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
A Study of Two Anti-HIV Drug Combinations
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