A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs, Some at Higher Than Usual Doses

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to see if 7 drugs, some of them given at higher doses than normal, are safe and tolerated by young patients with AIDS who have failed to respond to other treatments. The study will also see what effect taking several anti-HIV drugs together at high doses has on the body's ability to fight HIV infection. The 7 drugs that will be given in this study are stavudine (d4T), didanosine (ddI), lamivudine (3TC), nelfinavir (NFV), ritonavir (RTV), saquinavir (SQV), and nevirapine (NVP). (This study has been changed from an 8-drug regimen to a 7-drug regimen. Patients no longer receive the drug hydroxyurea \[HU\].) Doctors are seeing many HIV-positive children who did not get good long-term results from the current anti-HIV drugs. Some doctors believe anti-HIV drugs fail because drug levels in the body are too low. In this study, doctors will give patients 7 drugs, some at higher doses than normal. Since it is very important that patients on the study take all of these drugs, doctors will make it as easy as possible. Doctors want to try this because children with advanced AIDS have few treatment choices.

Key facts

Study ID: NCT00001108
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 6
Expected to finish: 2000-06-01
Last updated by the study team: 2021-11-01

Who can join

Age: 4 and older, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients may be eligible for this trial if they:
Are HIV-positive.
Have HIV levels of 10,000 copies/ml or more.
Are between ages 4 and 22.
Have motivation and ability to conform to the complex treatment regimen.
Agree to practice abstinence or use 2 effective methods of birth control during the study and until 3 months after stopping the study drugs, if sexually active.
Have written informed consent from a parent or legal guardian if under age 18.
Have used at least 3 different nucleoside reverse transcriptase inhibitors (NRTIs) for at least 3 months each or have shown resistance to at least 3 different NRTIs.
Have used at least 1 nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 3 months each or have shown resistance.
Have used at least 2 different courses of a protease inhibitor (PI)-containing regimen, each of which was at least 6 months, or have evidence of mutations to at least 2 different PIs.
This study has been changed. The inclusion criteria reflects a change in the prior anti-HIV therapy required, age requirement, and the required CD4 and HIV levels.

You may not qualify if…

Patients will not be eligible for this trial if they:
Are allergic to even 1 study drug or have ever had to stop 1 of these drugs because of a bad reaction to it.
Have a history of diabetes, hepatitis C, hepatitis B, or certain diseases of the nervous system, heart, or pancreas.
Have had a serious infection within 14 days of starting the study.
Need certain drugs that interact with the study drugs. (See Technical Summary for more details.)
Are pregnant or breast-feeding.
Have had hepatitis within 30 days of study entry.

Where it is running

Univ of Alabama at Birmingham - Pediatric — Birmingham, Alabama, United States
UCLA Med Ctr / Pediatric — Los Angeles, California, United States
Univ of Miami (Pediatric) — Miami, Florida, United States
Sacred Heart Children's Hosp / CMS of Florida — Pensacola, Florida, United States
Cook County Hosp — Chicago, Illinois, United States
Chicago Children's Memorial Hosp — Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
Johns Hopkins Hosp - Pediatric — Baltimore, Maryland, United States
Children's Hosp of Boston — Boston, Massachusetts, United States
Univ of Massachusetts Med School — Worcester, Massachusetts, United States
Univ of Mississippi Med Ctr — Jackson, Mississippi, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
North Shore Univ Hosp — Great Neck, New York, United States
Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
Columbia Presbyterian Med Ctr — New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr — New York, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics — Syracuse, New York, United States
Saint Jude Children's Research Hosp of Memphis — Memphis, Tennessee, United States
Med College of Virginia — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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