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:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT00028366
Eligibility Criteria:
Note: Accrual into A5143 and A5147S has been discontinued. The study originally planned to enroll 216 participants, but only 56 participants were enrolled at the time of early termination of enrollment because of interim review results.
Inclusion Criteria for Step 1
* HIV infected
* Past anti-HIV therapy consisting of at least 1 PI-containing regimen or detectable viral load, and at least 1 year total anti-HIV therapy experience
* Viral load of more than 5000 copies/ml within 60 days prior to screening while on a stable anti-HIV therapy for at least 12 weeks
* Agree to use acceptable forms of contraception
Exclusion Criteria
* More than 7 days of treatment with LPV and/or more than 7 days of treatment with APV or fosamprenavir
* HIV vaccine within 90 days of study entry
* Experimental drugs within 30 days of study entry
* Cancer chemotherapy within 30 days of study entry
* Drugs that affect the immune system within 30 days of study entry
* Certain drugs within 14 days of study entry. Patients who have used drugs that might damage the kidneys within 7 days of study entry are allowed.
* Midazolam within 7 days of study entry
* Allergic or sensitive to study drugs
* Excessive drug or alcohol use
* Serious illness requiring treatment and/or hospitalization and have not completed therapy, or are not stable on therapy for at least 14 days prior to study entry
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00028366
Study Brief:
Protocol Section:
NCT00028366