The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT

Glaxo Wellcome325 enrolled

Overview

To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT. PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.

Patients are randomized to one of three treatment arms: low-dose 3TC plus AZT, high-dose 3TC plus AZT, or ddC plus AZT. Treatment continues for 32 weeks, with possible extension to 52 weeks. PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

325

Conditions

HIV Infections

Interventions

LamivudineDRUG

ZidovudineDRUG

ZalcitabineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria Patients must have: * HIV positivity. * CD4 count 100-300 cells/mm3. * Prior AZT therapy for 24 or more weeks and currently on AZT. Exclusion Criteria Patients with the following prior conditions are excluded: * History of intolerance to AZT. * History of grade 2 or worse peripheral neuropathy. Prior Medication: Excluded: * Any prior antiretroviral therapy other than AZT. Required: * Concomitant AZT therapy. Required: * At least 24 weeks of prior AZT.

Locations (22)

Combat Group

Los Angeles, California, United States

Data from ClinicalTrials.gov

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