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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT00830804
Eligibility Criteria:
Inclusion Criteria:
* HIV-1-infected
* Plasma HIV-1 RNA of at least 5,000 copies/mL within 90 days prior to study entry
* HIV genotype (for reverse transcriptase and protease) performed at any time prior to study entry. More information on this criterion can be found in the protocol.
* ARV drug-naive. More information on this criterion can be found in the protocol.
* Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry
* Agree to use one form of medically-accepted contraceptive throughout the study and for 60 days after stopping study treatment. More information on this criterion can be found in the protocol.
Exclusion Criteria:
* Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to study. More information on this criterion can be found in the protocol.
* Screening HIV genotype obtained any time prior to study entry with more than one DRV resistance-associated mutation \[RAM\] (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, I84V, and L89V) or L76V alone
* Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and G140S
* Severe renal insufficiency requiring hemodialysis or peritoneal dialysis
* Treatment with immunomodulators within 30 days prior to study entry. More information on this criterion can be found in the protocol.
* Current medications that are prohibited with any study medications. More information on this criterion can be found in the protocol.
* Known allergy/sensitivity to study drugs or their formulations. A history of sulfa allergy is not an exclusion.
* Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study.
* Certain abnormal laboratory results. More information on this criterion can be found in the protocol.
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00830804
Study Brief:
Protocol Section:
NCT00830804