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 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
NCT ID:
NCT02060006
Eligibility Criteria:
Inclusion Criteria:
* Males and non-pregnant females age 18 years of age or older
* Evidence of HIV-1 infection
* TB treatment (\<2 weeks) and initiating EFV-based antiretroviral therapy as per the South African Department of Health Guidelines
* Living in the study site catchment area and having had a known address for more than 3 months
* Written informed consent
Exclusion Criteria:
* History of aspirin sensitivity and allergies to other NSAIDs
* Current or recent use (\<3 months) of aspirin, NSAIDs, or anticoagulants such as warfarin.
* Current or recent use of corticosteroid therapy
* History of gastro-intestinal bleeding or peptic ulcer
* History of cardiovascular thrombotic events (myocardial infarction or stroke), hypertension, or congestive heart failure
* Severe renal impairment as evidenced by creatinine clearance \<50 (Cockcroft- Gault Formula)
* Severe liver disease (ALT \> five times upper limit of normal)
* Presence of a medical condition likely to result in death within 6 months from start of ART. These conditions include suspected or CNS lymphoma, PMLE and disseminated visceral Kaposi's sarcoma
* Cognitive disorder(s) that could impair ability to comply with study requirements, as determined by the study physician
* Karnofsky performance score \<60
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02060006
Study Brief:
Protocol Section:
NCT02060006