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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT00050895
Eligibility Criteria:
Inclusion Criteria for Step 1:
* HIV infected
* HIV viral load of 2000 copies/ml or greater within 60 days prior to study entry
* Willing to use acceptable means of contraception
* d4T XR, TDF, or ZDV chosen as part of an initial regimen prior to randomization to a study arm
* Coenrolled in ACTG A5152s
Exclusion Criteria for Step 1:
* On ARV therapy for 7 days or more any time prior to study entry
* NNRTIs or 3TC at any time prior to study entry
* Current peripheral neuropathy of Grade 2 or higher
* Pregnancy or breastfeeding
* Immunomodulators, vaccines, or investigational therapies within 30 days of study entry. Patients taking a stable or tapering dose of prednisone at less than 10 mg are not excluded.
* Human growth hormone within 30 days prior to study entry
* Initiation of testosterone or anabolic steroids within 30 days prior to study entry
* Certain other medications within 30 days of study entry
* Hypersensitivity to components of the study drug formulations
* Drug or alcohol use or dependence that would interfere with adherence to study requirements
* Acute therapy for serious medical illnesses requiring systemic treatment and/or hospitalization within 14 days prior to study entry
* Recent infection with drug-resistant HIV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00050895
Study Brief:
Protocol Section:
NCT00050895