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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00537394
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infection
* Triple-class drug experience or resistance. More information on this criterion can be found in the protocol.
* Currently on a failing PI-containing regimen that includes 2 other ARVs with no regimen change for 8 weeks prior to study screening
* HIV viral load of 1000 copies/ml or more
* Hepatitis B surface antigen negative within 90 days of study entry
* Able to obtain NRTIs and ritonavir and have required ARVs at time of starting study intervention
* Willing to use acceptable forms of contraception
* Parent or legal guardian willing to provide consent, if applicable
* CD4 count result from a specimen drawn within 120 days prior to study entry
* If any previous HIV-1 viral co-receptor tropism result is available, then most recent specimen date and the tropism result of that specimen AND specimen date and tropism result of any test with either X4 or D/M result, if different from the first specimen, must be available
Inclusion Criteria continued:
* Receipt of successful phenotype/genotype resistance results within 105 days prior to study treatment intervention assignment
* Study team identification of a study regimen and at least 2 NRTIs for participant to take
* Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
Exclusion Criteria:
* Chronic, active hepatitis B virus infection (hepatitis B surface antigen positive or HBV DNA positive)
* Taking certain medications. More information on this criterion can be found in the protocol.
* Known allergy/sensitivity to components of two or more of the study-provided drugs or their formulations. For maraviroc, this includes hypersensitivity or history of allergy to soy lecithin or peanuts.
* Active drug or alcohol use that, in the opinion of the investigator, may interfere with the study
* Pregnancy or breastfeeding
* Use of any immunomodulator (interferons, interleukins, systemic corticosteroids, or cyclosporine), vaccine, or investigational therapy within 30 days prior to study treatment allocation/assignment
* Require certain medications prohibited with study treatment
* Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study treatment allocation are not excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00537394
Study Brief:
Protocol Section:
NCT00537394