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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT00393120
Eligibility Criteria:
Inclusion Criteria:
Asymptomatic HIV-1 infected individuals that are treatmen naïve (ie less than 2 weeks prior ARV exposure) or treatment experienced subjects who are not currently on HAART and have not received any ARVs for 3 months prior to Screening.
* Males between 18 years and 65 years of age, utilizing adequate contraceptive methods.
* Post menopausal or surgically sterile females between 18 years and 65 years of age. Women of childbearing potential, utilizing adequate contraceptive methods.
* CD4-lymphocyte count \>350 cells/mm3
* HIV-1 RNA copies/ml \> 10,000.
* HIV-1 is CCR5 tropic virus only.
* CCR5 antagonist treatment naive.
* BMI \> 16 to \< 32 kg/m2.
* Have no clinically significant findings on screening evaluations, which in the opinion of the Investigator would interfere with the subject's ability to comply with the protocol.
* Able to comprehend and willing to sign an Informed Consent Form.
Exclusion Criteria:
* Current or recent (\<30 days) opportunistic infection.
* Presence of CXCR4- or dual-tropic HIV-1 virus at Screening or Baseline assessments.
* Subjects with chronic renal insufficiency
* Personal history of cardiac diseases.
* History or presence of an abnormal ECG.
* History of unstable ischemic heart disease or uncontrolled hypertension.
* History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
* Subjects who have received radiation therapy or cytotoxic chemotherapeutic agents and have not recovered from side effects.
* Current treatment or treatment within 30 days or 5 half-lives with another investigational medication or current enrollment in another investigational drug protocol.
* Subjects with unstable medical condition (s), which , in the opinion of the Investigator would compromise their participation in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00393120
Study Brief:
Protocol Section:
NCT00393120