Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT00084058
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT00084058
Study Brief:
Protocol Section:
NCT00084058