A Study of Nystatin in HIV-Infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Nystatin

Intervention Type DRUG

Didanosine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Twelve Oaks Hosp

Houston, Texas, United States

Site Status

Countries

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United States

References

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Rios A, Brewton G, Crofoot G, Quesada J, Lenk R, Lopez-Berenstein G. A phase I-II clinical study of Nystatin-LF IV in patients with HIV infections. Int Conf AIDS. 1993 Jun 6-11;9(1):483 (abstract no PO-B26-2089)

Reference Type BACKGROUND

Other Identifiers

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AR-91-35,606-005A

Identifier Type: -

Identifier Source: secondary_id

103C