A Study of Nystatin in HIV-Infected Patients

Argus Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Didanosine; Drug: Nystatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002313

AR-91-35,606-005A

103C

Details and patient eligibility

About

To evaluate the clinical toxicity, safety, and potential anti-HIV activity of intravenous nystatin in patients with HIV infection who have completed protocol FDA 103C. To evaluate the safety and potential antiviral activity of intravenous nystatin and oral didanosine (ddI) administered in an alternating regimen in this patient population.

Full description

Patients who have completed protocol FDA 103B are offered the option of receiving extended maintenance. Patients who have received no prior ddI are treated either with intravenous nystatin alone (at the same dose level administered in FDA 103B) or with a regimen of intravenous nystatin and ddI alternating on 3-week cycles. Treatment continues for 12 weeks.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have:

• Completed 12 weeks of therapy with intravenous nystatin on protocol FDA 103B.
• No evidence of toxicity or progression of disease on protocol FDA 103B. (See protocol FDA 103B for initial entry requirements.)

Active drug or alcohol abuse.