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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002210
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1998
  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 2

Study Type: Interventional
Study Design: Primary Purpose: 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:


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

Estimated Enrollment: 24
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)

ClinicalTrials.gov Identifier: NCT00002210     History of Changes
Other Study ID Numbers: 228D, 0069
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Delavirdine
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 28, 2014