Back to resultsA Study of Delavirdine Mesylate in Combination With Other Anti-HIV Drugs in HIV-Infected Children and Babies
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Delavirdine mesylate
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, Delavirdine, Reverse Transcriptase Inhibitors
Eligibility Criteria
Inclusion Criteria Patients must have: HIV infection. Plasma HIV-1 levels greater than 10,000 copies/ml.
Sites / Locations
- Pharmacia & Upjohn
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002210
Brief Title
A Study of Delavirdine Mesylate in Combination With Other Anti-HIV Drugs in HIV-Infected Children and Babies
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pharmacia and Upjohn
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, Delavirdine, Reverse Transcriptase Inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Delavirdine mesylate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
HIV infection.
Plasma HIV-1 levels greater than 10,000 copies/ml.
Facility Information:
Facility Name
Pharmacia & Upjohn
City
Peapack
State/Province
New Jersey
ZIP/Postal Code
07977
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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)
Results Reference
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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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