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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00002219
Other study ID # 232H
Secondary ID GS-97-418
Status Active, not recruiting
Phase Phase 2
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date November 1999
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 36
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 16 Years
Eligibility Inclusion Criteria

Your child may be eligible for this study if he/she:

- Is 3 months to 16 years old.

- Is HIV-positive.

- Has never taken protease inhibitors or has previously taken ritonavir (RTV), saquinavir (SQV), or indinavir (IDV) and is willing to stop the medication at study entry.

- Is taking an anti-HIV drug combination that will not change during at least the 2 weeks prior to study entry.

- Agrees to use effective barrier methods of birth control, such as condoms, during the study.

- Has consent of parent or guardian.

Exclusion Criteria

Your child will not be eligible for this study if he/she:

- Has ever taken NFV.

- Has a history of opportunistic (AIDS-related) infection.

- Has any disease or illness that would prevent him/her from completing the study, including cancer.

- Has taken certain medications, including protease inhibitors at study entry.

- Is receiving an HIV vaccine at study entry.

- Is pregnant.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Nelfinavir mesylate

Levocarnitine

Adefovir dipivoxil


Locations

Country Name City State
United States Bronx Lebanon Hosp Ctr / Dept of Pediatrics Bronx New York
United States Med Univ of South Carolina Charleston South Carolina
United States Duke Univ Med Ctr / Duke South Hosp Durham North Carolina
United States North Shore Univ Hosp / Division of Immunology Great Neck New York
United States Tulane Univ Med Ctr / Dept of Pediatrics New Orleans Louisiana
United States St Lukes Roosevelt Hosp Ctr New York New York
United States All Children's Hosp St. Petersburg Florida

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

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