A Study of Delavirdine Mesylate in Combination With Other Anti-HIV Drugs in HIV-Infected Children and Babies - Full Text View

A Study of Delavirdine Mesylate in Combination With Other Anti-HIV Drugs in HIV-Infected Children and Babies

This study has been completed.

Sponsored by:	Pharmacia and Upjohn
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002210

Purpose

The purpose of this study is to see if it is safe and effective to give delavirdine mesylate (Rescriptor) plus two nucleoside reverse transcriptase inhibitors (NRTIs) to HIV-infected children and babies. This study also examines how the body processes Rescriptor when taken with 2 NRTIs.

Condition	Intervention	Phase
HIV Infections	Drug: Delavirdine mesylate	Phase II

MedlinePlus related topics:

AIDS

Drug Information available for:

Delavirdine mesylate Delavirdine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Official Title:	Phase II Study of the Safety, Tolerance, Pharmacokinetics, and Antiviral Effect of Delavirdine Mesylate (Rescriptor), in Combination With Nucleoside Reverse Transcriptase Inhibitors, in HIV-1-Infected Neonates, Infants, and Children

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

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	1 Month to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

HIV infection.
Plasma HIV-1 levels greater than 10,000 copies/ml.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002210

Locations


United States, New Jersey
	Pharmacia & Upjohn
	Peapack, New Jersey, United States, 07977

Sponsors and Collaborators

Pharmacia and Upjohn

More Information

Publications:

Willoughby R, Watson D, Welliver R. Early use of RESCRIPTOR (delavirdine) in children with HIV. 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29 (abstract no 1995)

Study ID Numbers:	228D, 0069
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002210
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1

Drug Therapy, Combination

Delavirdine

Reverse Transcriptase Inhibitors

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Delavirdine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

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

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008