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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT00144157
Eligibility Criteria:
INCLUSION CRITERIA
* HIV-1-infected non-pregnant women who received a nevirapine regimen, for the prevention of mother to child transmission, at least 12 months previously.
* Women of child-bearing potential must have a negative urine pregnancy test at the screening visit and ensure double barrier methods of contraception, which by definition will in all cases include the use of condoms, throughout the study period.
* CD4 cell count \< 350 cells/mm3 and viral load HIV-1 RNA \> 20,000 c/mL or any symptomatic individual (WHO stage 3) or the presence of any AIDS defining criteria.
* Documented HIV-1 positive status by a licensed HIV-1 ELISA test.
EXCLUSION CRITERIA
* Women who are pregnant or breastfeeding.
* Women with prior exposure to antiretroviral therapy, other than a nevirapine regimen for the prevention of mother to child transmission at least 12 months previously.
* Subjects who in the investigator's opinion are unlikely to complete the 48 week study period or unlikely to comply with the dosing schedule and protocol evaluations.
* Patients with a Karnofsky performance status score \< 70.
* Subjects who fail to meet the HIV treatment criteria (CD4 and viral load) indicated above.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Maximum Age:
45 Years
Study:
NCT00144157
Study Brief:
Protocol Section:
NCT00144157