Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
4-22 years
Phase:
PHASE1
Brief Summary
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 s...
Detailed Description
Clinicians are increasingly confronted with HIV-positive children who have failed all available antiretroviral therapies and have few viable treatment options. Virologic failure in these patients may ...
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 2000
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00001108
End Date
June 1 2000
Last Update
November 1 2021
Active Locations (19)
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1
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States, 35233
2
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
3
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
4
Sacred Heart Children's Hosp / CMS of Florida
Pensacola, Florida, United States, 32503