Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial

Recruiting in Palo Alto (17 mi)

+42 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Pharmacia

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to placebo, and to assess if survival is prolonged in patients who receive rifabutin prophylaxis.

Research Team

Eligibility Criteria

Inclusion Criteria

Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).

Written informed consent obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant.