Status:
COMPLETED
Safety of Saquinavir and High Doses of Lopinavir/Ritonavir in Children With HIV
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
2-17 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the effect of increased doses of lopinavir/ritonavir (LPV/r) and saquinavir (SQV) in HIV infected children who are failing their current antiretroviral regime...
Detailed Description
Since current drugs cannot cure HIV infection, lifelong therapy is required. Development of drug resistance is common, with 30% to 80% of patients with initial viral load decreases following a potent ...
Eligibility Criteria
Inclusion
- HIV infected
- HIV RNA viral load greater than 5,000 copies/ml
- At least 6 months of continuous therapy with a protease inhibitor (PI) prior to study entry
- No change in antiretroviral therapy since genotypic resistance testing
- Genotypic resistance testing indicating a primary protease mutation at position 32, 47, 48, 50, 82, or 84 and at least three other mutations in positions 10, 20, 24, 30, 32, 33, 36, 46, 47, 48, 50, 53, 54, 71, 73, 77, 82, 84, or 90 OR phenotypic resistance testing, within 6 months of screening while on a failing regimen, indicating at least a fivefold increase in LPV as compared to wild type HIV
- Parent or legal guardian willing to provide informed consent
- If sexually active, agree to use acceptable methods of contraception
- Have a telephone, pager, or other method of reliable communication with study staff
- Able and willing to swallow study medications
Exclusion
- Any drug toxicity greater than Grade 3 at screening
- Certain abnormal laboratory values
- Acute opportunistic or serious bacterial infection requiring treatment
- Chemotherapy for active cancer
- Any significant diseases (other than HIV infection) that may, in the opinion of the investigator, interfere with the study
- Require certain medications
- History of heart problems
- Family history of prolonged QTc-Interval Syndrome or prolonged QTc-interval at study entry
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00084058
End Date
December 1 2006
Last Update
November 1 2021
Active Locations (15)
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1
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35233
2
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
3
UCSF Pediatric AIDS CRS
San Francisco, California, United States, 94143-0105
4
Chicago Children's CRS
Chicago, Illinois, United States, 60614