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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT01423812
Eligibility Criteria:
Inclusion Criteria:
1. ART-experienced, HIV-1 infected subjects ≥18 years of age.
2. A female subject is eligible to enter and participate in the study if she:
1. is of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or,
2. is of child-bearing potential, with a negative pregnancy test at both Screen and Day 1 and agrees to one of the following methods of contraception to avoid pregnancy:
* Complete abstinence from intercourse from 2 weeks prior to administration of study medications, throughout the study, and for at least 2 weeks after discontinuation of all study medications.
* Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide).
* Approved hormonal contraception may be administered with darunavir/ritonavir
* Any intrauterine device (IUD) with published data showing that the expected failure rate is \<1% per year
* Any other method with published data showing that the expected failure rate is \<1% per year.
Any contraception method must be used consistently and in accordance with the approved product label. All subjects participating in the study should be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide).
3. CD4 \>50 cells/mm3
4. HIV-1 RNA concentrations at undetectable levels (according to local assay being used) for at least 12 weeks on stable current regimen
5. Current regimen includes darunavir/ritonavir 600/100 mg twice-daily plus a minimum of two other antiretrovirals
6. Negative serum pregnancy test at screening visit
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
1. Known hypersensitivity reaction to agents being utilized in the study
2. \>1 cumulative darunavir associated mutations (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V, or L89V) detected from any previous genotype or a VircoTYPE HIV-1 darunavir fold-change \>10.0 on any previous virtual phenotype
3. Pregnant or breast feeding woman
4. Liver dysfunction with Child-Pugh class C disease or decompensated cirrhosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01423812
Study Brief:
Protocol Section:
NCT01423812