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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00752856
Eligibility Criteria:
Inclusion Criteria:
* Documented HIV-1 infection.
* Treatment naïve (defined as having never received any HIV antiretroviral agents in past).
* CD4+ T-cell count greater than or equal to 50 cells/mm3
* HIV viral load greater than or equal to 5,000 copies/mL
* Laboratory values obtained by screening laboratories within 30 days of entry:
* Absolute neutrophil count (ANC) greater than 750/mm3.
* Hemoglobin greater than 8.0 g/dL.
* Platelet count greater than 50,000/mm3.
* Calculated creatinine clearance (CrCl) \> 60 mL/min as estimated by the Cockcroft-Gault equation:
* For men, (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dL x 72) = CrCl (mL/min)
* For women, multiply the result by 0.85 = CrCl (mL/min)
* AST (SGOT), ALT (SGPT), and alkaline phosphatase less than 5 x ULN.
* Total bilirubin less than 2.5 x ULN.
* Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
* Men and women age greater than or equal to 18 years.
* Ability to obtain prescription for HIV antiretroviral medications and to have required prescriptions filled prior to entry.
* Ability and willingness of subject to give written informed consent
Exclusion Criteria:
* Pregnancy or breast-feeding
* Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 30 days prior to study entry (day 0).
* Acute therapy for serious infection or other serious medical illnesses (in the judgment of the site investigator) requiring systemic treatment and/or hospitalization within 14 days prior to study entry (day 0).
* Evidence of HIV seroconversion within 6 months prior to study entry.
* Evidence of any major HIV drug resistance-associated mutation on any genotype performed prior to study entry or at the time of screening.
* History of chronic hepatitis C (defined as HCV antibody positive and HCV RNA detectable).
* History of chronic active hepatitis B (defined as surface antigen positive and/or HBV DNA detectable).
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
* Use of any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study entry.
* Use of human growth hormone within 30 days prior to study entry.
* Initiation of testosterone or anabolic steroids within 30 days prior to study entry. (Exception: Chronic replacement dosages in patient's with diagnosed hypogonadism is allowed).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00752856
Study Brief:
Protocol Section:
NCT00752856