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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT00214435
Eligibility Criteria:
Inclusion Criteria:
* aged 18 years or more with laboratory evidence of HIV-1 infection
* ability to understand and provide written informed consent to participate in the study
* stable on current ART regimen for at least 3 months prior to screening.
* plasma HIV-RNA less than 400 copies/ml at the screening visit.
* women of child bearing potential must have a negative serum or urine β-HCG pregnancy test within 14 days prior to week -4 (assessment of study eligibility)
Exclusion Criteria:
* virological failure of a proposed Once daily arm medication
* a serious medical condition which may compromise the subject's safety, including an active AIDS-defining condition within the previous 6 months
* known toxicities to any of the proposed Once daily arm medications
* laboratory abnormalities at screening:
* serum creatinine greater than twice the upper limit of normal (2 x upper limit of normal (ULN))
* AST, ALT or alkaline phosphatase greater than 5 times the ULN
* lactate greater than 2.5 x ULN
* haemoglobin less than 9.5 g/dL
* women who are pregnant or breast-feeding or who, if of child-bearing potential, are not willing to use adequate contraception (including barrier contraception)
* patients who in the investigator's opinion are unlikely to complete the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00214435
Study Brief:
Protocol Section:
NCT00214435