A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the clinical toxicity, safety, and maximum tolerated dose (MTD) of intravenous nystatin in patients with HIV infection. To evaluate the potential anti-HIV activity and clinical pharmacology of intravenous nystatin.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cohorts of three patients each are treated at escalating doses of intravenous nystatin, administered every other day, until the MTD is reached. Each cohort is observed for toxicity for at least 2 weeks before escalation in subsequent patient cohorts is initiated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nystatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Concurrent Medication:

Required:

* Aerosolized pentamidine (300 mg once a month) for PCP prophylaxis in patients with CD4 count \<= 200 cells/mm3. (Patients with CD4 count \> 200 cells/mm3 who are already on aerosolized pentamidine may continue such therapy at the discretion of the investigator.)

Allowed:

* Prophylaxis against Mycobacterium avium Complex in patients with CD4 count \<= 100 cells/mm3.

Concurrent Treatment:

Allowed:

* Local treatment for Kaposi's sarcoma lesions with less than 25 percent increase in measurable disease.

Patients must have:

* HIV antibody positivity.
* Absolute CD4 count \< 500 cells/mm3 on two determinations within 15 days prior to study entry.
* At least 6 months of prior zidovudine (AZT) therapy.
* No active opportunistic infection requiring ongoing therapy.
* Normal neurologic status by standard assessment.
* Life expectancy of at least 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Neoplasm other than basal cell carcinoma of the skin or stable untreated HIV-related Kaposi's sarcoma (provided there is no progression in the Kaposi's sarcoma beyond 25 percent of measurable disease).
* Clinically significant cardiac disease.
* Known hypersensitivity to polyene antibiotics.

Patients with the following prior conditions are excluded:

* History of myocardial infarction or arrhythmias.

Prior Medication:

Excluded within 2 weeks prior to study entry:

* Antiretroviral agents or interferons.
* Biological response modifiers.
* Corticosteroids.
* Cytotoxic chemotherapeutic agents.
* Drugs that can cause neutropenia or significant nephrotoxicity.
* Rifampin or rifampin derivatives.
* Systemic anti-infectives.

Prior Treatment:

Excluded within 2 weeks prior to study entry:

* Radiation therapy. Active drug or alcohol abuse.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Twelve Oaks Hosp

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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

Review additional registry numbers or institutional identifiers associated with this trial.

AR-91-35,606-004

Identifier Type: -

Identifier Source: secondary_id

103B