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:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT00038506
Eligibility Criteria:
Inclusion Criteria:
* Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).
* Plasma HIV - 1 RNA was \<400 copies/ml on at least 2 documented occasions prior to viral rebound.
* Have a plasma HIV - 1 RNA value \>400 copies/ml and \<10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.
* A CD4+ lymphocyte count less than or equal to 100.
Exclusion Criteria:
* Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.
* Have not had an AIDS defining illness within 30 days of screen.
* Pregnant or breast-feeding.
* Specified viral genotypes upon screening.
* And other inclusion or exclusion criteria to be evaluated by the physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00038506
Study Brief:
Protocol Section:
NCT00038506