NCT00002210

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 1998

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1Drug Therapy, CombinationDelavirdineReverse Transcriptase Inhibitors

Interventions

Delavirdine mesylateDRUG

Eligibility Criteria

Age1 Month - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmacia & Upjohn

Peapack, New Jersey, 07977, United States

Location

Related Publications (1)

  • 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)

    BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Delavirdine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1998-01

Locations

US(1)