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 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT00089505
Eligibility Criteria:
Inclusion Criteria for All Participants:
* HIV infected
* CD4 count less than 200 cells/mm\^3 within 90 days prior to study entry
* Plasma HIV-1 RNA using standard Roche Amplicor HIV-1 Monitor Assay within 45 days prior to study entry
* the following laboratory values obtained within 45 days prior to study entry: absolute neutrophil count\>=750/mm\^3;Hemoglobin\>=7.0g/dL;platelet count\>=50000/mm\^3;aspartate aminotransferase (AST),Alanine aminotransferase (ALT), and alkaline phosphatase \<=2.5 x ULN; total bilirubin \<=2.5 x ULN
* Normal renal function within 45 days prior to study entry
* Willing to use acceptable forms of contraception
* Karnofsky performance score \>=70 on at least one occasion within 45 days prior to study entry
* Parent or guardian willing to provide informed consent, if applicable
* Planning to remain in the same geographical area of residence and are willing to attend study visits as required
Inclusion Criteria for Trial 1 Participants:
* Previously received NVP for prevention of MTCT of HIV
* Has documentation of all prior doses of NVP used for prevention of MTCT of HIV
* Last dose of NVP for prevention of MTCT of HIV taken at least 6 months prior to study entry
Exclusion Criteria for All Participants:
* Previously received any antiretrovirals, excluding NVP for MTCT prophylaxis for Trial 1 participants. Participants who have received up to 10 weeks of zidovudine alone and completed this course at least 6 months prior to study entry are not excluded.
* Use of systemic cancer chemotherapy, systemic investigational agents, immunomodulators, or rifampin within 30 days of study entry
* Pregnant or breastfeeding
* Known allergy or sensitivity to study drugs or their formulations
* Any condition, including drug or alcohol abuse, that, in the opinion of the investigator, may interfere with adherence to study regimens
* Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 30 days prior to study entry are not excluded.
* Tuberculosis (TB) treatment within 30 days prior to study entry
* Use of any prohibited medications within 30 days prior to study entry
* Involuntary incarceration in a correctional facility, prison, or jail for legal reasons or in a medical facility for treatment of either a psychiatric or physical illness
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
13 Years
Study:
NCT00089505
Study Brief:
Protocol Section:
NCT00089505