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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Lamivudine; Zalcitabine; Zidovudine

Criteria

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.