A Study of Nystatin in HIV-Infected Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Nystatin Drug: Didanosine	Phase I

MedlinePlus related topics:

AIDS

Drug Information available for:

Didanosine Nystatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison, Safety Study

Official Title:	Extended Maintenance Protocol for Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection (NOTE: Continuation Study Intended Only for Patients Who Have Completed FDA 103B)

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002313

Locations


United States, Texas
	Twelve Oaks Hosp
	Houston, Texas, United States, 77027

Sponsors and Collaborators

Argus Pharmaceuticals

More Information

Publications:

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)

Study ID Numbers:	103C, AR-91-35,606-005A
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002313
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Nystatin

Didanosine

Drug Therapy, Combination

Acquired Immunodeficiency Syndrome

AIDS-Related Complex

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral

Clotrimazole

Miconazole

Acquired Immunodeficiency Syndrome

Tioconazole

AIDS-Related Complex

Nystatin

Immunologic Deficiency Syndromes

Virus Diseases

Didanosine

HIV Infections

Sexually Transmitted Diseases

Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Communicable Diseases

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Membrane Transport Modulators

Anti-Bacterial Agents

Anti-Retroviral Agents

Antifungal Agents

Therapeutic Uses

Lentivirus Infections

Ionophores

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	Argus Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002313