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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT01335620
Eligibility Criteria:
Inclusion Criteria:
1. HIV-1 infected males or females
2. 60 years of age or greater\*
3. signed informed consent
4. willing to switch therapy as per study protocol
5. no previous exposure to raltegravir or HIV-1 integrase inhibitors
6. plasma HIV RNA \< 50 copies/mL at screening and on at least one other occasion over the last 3 months
7. currently receiving a stable antiretroviral regimen with no antiretroviral drug switches for at least 3 months
8. no previous clinically-significant resistance documented on HIV-1 genotypic resistance
9. subjects in good health upon medical history, physical exam, and laboratory testing
10. BMI above or equal to 18 and below 32
11. Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study.
12. Have local screening laboratory results (haematology and chemistry that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance \* 50% of total enrolled cohort will be 65 years of age or over. Subsequent to 10 subjects aged between 60 and 64 recruited, only subjects aged 65 or over will be eligible.
Exclusion Criteria:
1. current alcohol abuse or drug dependence
2. positive urine drug of abuse screening
3. active opportunistic infection or significant co-morbidities
4. current disallowed concomitant medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01335620
Study Brief:
Protocol Section:
NCT01335620