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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Delavirdine Delavirdine mesylate

U.S. FDA Resources

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
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002210 History of Changes
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
Anti-HIV Agents
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Delavirdine
Antiviral Agents
Retroviridae Infections
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Delavirdine
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 02, 2009