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 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT00225303
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age 18 years or older
* Documented HIV-1 infection
* Stable NNRTI-containing ART (minimum 12 weeks) at screening OR treatment interruption (minimum 4 weeks) at screening OR having received an NNRTI alone or in combination with other ARVs for prevention of MTCT
* Plasma viral load at screening above 1000 HIV-1 RNA copies/ml
* Prior NNRTI-experience with documented genotypic evidence of resistance to currently available NNRTIs (defined as at least one NNRTI-associated mutation per IAS-USA Drug resistance Mutation guidelines)
* Sensitive to the 2 NRTIs to be used as underlaying ART
* Subject has given informed consent
Exclusion Criteria:
* Previous treatment with Protease Inhibitors
* Presence of any currently active AIDS defining illness except stable cutaneous Kaposi's Sarcoma and Wasting syndrome due to HIV infection
* Current or past history of alcohol and/or drug use which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures
* Acute Hepatitis A, B or C or chronic hepatitis B or C with elevated LFTs of \> 3 times ULN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00225303
Study Brief:
Protocol Section:
NCT00225303