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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00192660
Eligibility Criteria:
Inclusion Criteria:
* Age \>18.
* Be able to provide written consent to perform in the trial.
* HIV antibody positive at time of entry to the study.
Specific to HIV Infection and Metabolic Abnormalities Protocol 1 (HAMA) part A only:
* Be naive to antiretroviral medication.
Specific to HAMA part B only:
* Have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.
* Have had a minimum of 48 weeks interval since completion of HAMA part A.
Exclusion Criteria:
* Any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subject's ability to participate in the trial.
* Prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.
* Prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.
* Alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.
* Prior use of any retinoid-containing compound within the previous six months.
* Abnormal coagulation.
* Previous allergic reaction or known allergy to local anaesthetic.
* Previous or concomitant use of medications, which, in the opinion of the investigator, would affect the subject's ability to participate in all activities involved in the trial.
* Any grade-three laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subject's ability to safely complete all study requirements.
* Any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subject's ability to participate in the rest of the trial.
* Pregnancy
Specific to HAMA part A only:
* Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors). Entry of individuals who have had previous antiretroviral therapy as part of post exposure prophylaxis will be at the discretion of the study investigators.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00192660
Study Brief:
Protocol Section:
NCT00192660