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

A Phase I/II, Open-Label, Multi-Center Study of the Pharmacokinetics, Safety, Tolerance and Activity of Two Dose Levels of Adefovir Dipivoxil (ADF) and Nelfinavir When Added to Antiretroviral Therapy for the Treatment of HIV-Infected Pediatric Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002219

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Dose-Response Relationship, Drug, Antiviral Agents, HIV Protease Inhibitors, Disease Progression, RNA, Viral, Adenine, Viral Load, Age Factors, Nelfinavir

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.

Interventions

DRUGNelfinavir mesylate

DRUGLevocarnitine

DRUGAdefovir dipivoxil

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

3 Months to 16 Years

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026