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 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT01088295
Eligibility Criteria:
Inclusion Criteria:
* HIV positive men and women 18 years and older
* HIV-1 infection as documented by ELISA and confirmed by Western blot or plasma HIV-1 RNA \>2000 on two occasions
* Documented central fat accumulation
* HIV RNA documented to be less than 50 copies/mL at screening and undetectable by assay of choice for at least 12 weeks prior to entry
* Current antiretroviral therapy with a suppressive, highly active antiretroviral regimen.
* Systolic BP \>115mmHg.
* Ability and willingness to provide informed consent
Exclusion Criteria:
* Pregnancy (current or within the last 6 months) or nursing
* Uncontrolled hypertension
* Prohibited concomitant medications
* Subjects with untreated hyperlipidemia must be willing to abstain from initiating therapy for the 24 week duration fo the study.
* Subjects undergoing treatment for diabetes with oral hypoglycemic agents must be willing to remain on their current dose of insulin sensitizing agents for the duration of the study.
* Known, untreated renal artery stenosis
* Unstable coronary artery disease/angina or decompensated congestive heart failure.
* Any history of intolerance to any member of the angiotensin receptor blocker class of agents.
* Need for ongoing potassium supplementation.
* Screening laboratory values as follows ANC (absolute neutrophil count) \<750 cells/mm3 Hemoglobin \<10 gm/dL ClCr (creatinine clearance)\< 30 ml/min (estimated by Cockcroft-Gault equation) AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \> 3 x ULN (upper limit of normal)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01088295
Study Brief:
Protocol Section:
NCT01088295