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

NCT ID: NCT00002219

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Nelfinavir mesylate

Intervention Type DRUG

Levocarnitine

Intervention Type DRUG

Adefovir dipivoxil

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Locations

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All Children's Hosp

St. Petersburg, Florida, United States

Site Status

Tulane Univ Med Ctr / Dept of Pediatrics

New Orleans, Louisiana, United States

Site Status

North Shore Univ Hosp / Division of Immunology

Great Neck, New York, United States

Site Status

St Lukes Roosevelt Hosp Ctr

New York, New York, United States

Site Status

Bronx Lebanon Hosp Ctr / Dept of Pediatrics

The Bronx, New York, United States

Site Status

Duke Univ Med Ctr / Duke South Hosp

Durham, North Carolina, United States

Site Status

Med Univ of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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GS-97-418

Identifier Type: -

Identifier Source: secondary_id

232H

Identifier Type: -

Identifier Source: org_study_id