Status:
COMPLETED
A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy
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
4-21 years
Phase:
PHASE2
Brief Summary
HIV infected children and adolescents who have taken many anti-HIV drugs may have limited treatment options and are at high risk for progressing to AIDS. The purpose of this study is to determine whet...
Detailed Description
HIV infected children and adolescents on anti-HIV treatment regimens have traditionally had more difficulty with non-adherence and drug resistance than adults, often resulting in virologic failure. Ad...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Step I:
- HIV infected
- No currently available therapeutic options that would likely result in long-term suppression of virus to less than 400 copies/ml
- Two measurements within 4 months prior to screening and at screening of either CD4% of less than 15% and HIV viral load of greater than 10,000 copies/ml OR HIV viral load greater than 30,000 copies/ml
- Previous exposure to non-nucleoside reverse transcriptase inhibitors (NNRTIs), NRTIs, and PIs AND have experienced virologic failure. More information on previous treatment regimen requirements is available in the protocol.
- Prior or current virologic failure with genotypic or phenotypic resistance OR historical virologic failure with a PI- or NNRTI-containing regimen
- Resistance to 2 or more drugs in most recent treatment regimen within 26 weeks prior to study screening
- Able and willing to swallow study medications
- Parent or guardian willing to provide informed consent, if applicable
- Willing to use acceptable methods of contraception
- Exclusion Criteria for Step I:
- Previous cumulative exposure to TDF for more than 24 weeks OR more than 14 days of TDF exposure during the 24 weeks prior to study entry
- Grade 1 lipase or higher within 28 days prior to study entry
- Grade 3 or higher laboratory abnormality (except for lipase) within 28 days prior to study entry
- History of allergy or hypersensitivity to any of the study drugs
- Active CDC Stage C opportunistic infection or serious bacterial infection requiring therapy at the time of screening
- Chemotherapy for active cancer
- Require certain medications
- Abnormal kidney function
- Any clinically significant diseases other than HIV infection or findings during medical history screening that, in the opinion of the investigator, may interfere with the study
- Pregnancy or breastfeeding
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00102206
End Date
May 1 2007
Last Update
November 1 2021
Active Locations (4)
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1
Chicago Children's CRS
Chicago, Illinois, United States, 60614
2
Columbia IMPAACT CRS
New York, New York, United States
3
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States, 11794-8111
4
DUMC Ped. CRS
Durham, North Carolina, United States, 27710