Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.
Detailed Description
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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.
Conditions
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Study Design
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PARALLEL
TREATMENT
Interventions
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Lamivudine/Zidovudine
Lamivudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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Pacific Oaks Med Ctr
Beverly Hills, California, United States
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, United States
Univ of North Carolina Hosps
Chapel Hill, North Carolina, United States
Carolinas Med Ctr
Charlotte, North Carolina, United States
Infectious Diseases Physicians Inc
Annandale, Virginia, United States
Univ of Wisconsin School of Medicine
Madison, Wisconsin, United States
San Juan AIDS Program
Santurce, , Puerto Rico
Countries
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Other Identifiers
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NZTA4001
Identifier Type: -
Identifier Source: secondary_id
280A
Identifier Type: -
Identifier Source: org_study_id