The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex

Recruiting in Palo Alto (17 mi)

+40 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

To determine the safety and usefulness of zidovudine (AZT) for the treatment of patients with early symptomatic HIV infection or early AIDS related complex (ARC). The ability of AZT to suppress HIV, to improve body defenses, and to prevent the occurrence or development of AIDS or advanced ARC is being evaluated. In one human study, patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections, improved in weight and performance, and lived longer than patients who received a placebo (inactive medication). Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown. It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL.

Research Team

MA Fischl

Principal Investigator

DD Richman

Principal Investigator

Eligibility Criteria

Inclusion Criteria

Patients must have a positive antibody to HIV confirmed by a federally licensed ELISA test kit.

The CD4 cell count must be 201 - 799 cells/mm3 measured on two separate occasions within 60 days at least 72 hours apart prior to study entry (at least 1 of 2 counts and the mean must be < 800 cells/mm3, and at least 1 of 2 counts and the mean must be > 200 cells/mm3). The last count must be within 14 days of study entry.

Acetaminophen and acetaminophen products but use should be minimized. Continuous use for > 72 hours is discouraged.

See 2 more