Clinical trial NCT00002219: Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HIV Infections
Keywords: Dose-Response Relationship, Drug
Antiviral Agents
HIV Protease Inhibitors
Disease Progression
RNA, Viral
Adenine
Viral Load
Age Factors
Nelfinavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: All Children's Hosp
state: Florida
city: New Orleans
country: United States
facility: Tulane Univ Med Ctr / Dept of Pediatrics
state: Louisiana
city: Bronx
country: United States
facility: Bronx Lebanon Hosp Ctr / Dept of Pediatrics
state: New York
city: Great Neck
country: United States
facility: North Shore Univ Hosp / Division of Immunology
state: New York
city: New York
country: United States
facility: St Lukes Roosevelt Hosp Ctr
state: New York
city: Durham
country: United States
facility: Duke Univ Med Ctr / Duke South Hosp
state: North Carolina
city: Charleston
country: United States
facility: Med Univ of South Carolina
state: South Carolina
Study officials:
References: