MedPath

Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children

Phase 2
Conditions
HIV Infections
Registration Number
NCT00002219
Lead Sponsor
Gilead Sciences
Brief Summary

The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.

Detailed Description

During the first phase of the study (Days 1-6), the safety and tolerability of multiple doses of ADF is assessed when administered simultaneously with the patient's reverse transcriptase inhibitor (RTI) regimen. The second phase begins on Day 7 when nelfinavir is added to the therapy regimen for an additional 15 weeks. ADF pharmacokinetics are measured on Days 1, 2, and 7 (on a subset of 18 patients); peak and trough samples are collected on Day 28.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
36
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

Bronx Lebanon Hosp Ctr / Dept of Pediatrics

🇺🇸

Bronx, New York, United States

St Lukes Roosevelt Hosp Ctr

🇺🇸

New York, New York, United States

Tulane Univ Med Ctr / Dept of Pediatrics

🇺🇸

New Orleans, Louisiana, United States

All Children's Hosp

🇺🇸

St. Petersburg, Florida, United States

Med Univ of South Carolina

🇺🇸

Charleston, South Carolina, United States

North Shore Univ Hosp / Division of Immunology

🇺🇸

Great Neck, New York, United States

Duke Univ Med Ctr / Duke South Hosp

🇺🇸

Durham, North Carolina, United States

© Copyright 2025. All Rights Reserved by MedPath