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

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ClinicalTrials.gov Identifier: NCT00002210
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Delavirdine mesylate Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients must have:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002210

United States, New Jersey
Pharmacia & Upjohn
Peapack, New Jersey, United States, 07977
Sponsors and Collaborators
Pharmacia and Upjohn

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
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Reverse Transcriptase Inhibitors

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