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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT02660905
Eligibility Criteria:
Inclusion Criteria:
* HIV infected (ELISA with western blot confirmation)
* HCV RNA positive for minimum of 6 months / Genotype 1
* Prescribed cART that may include any Department of Health and Human Services (DHHS) recommended or alternative regimens, which the treating physician considers, is appropriate for their patient. (We anticipate that approximately 60% will be on HIV protease inhibitor-based regimens).
* HIV RNA BLLQ for minimum of 3 months
* Stage 3 or 4 fibrosis
* No evidence of liver decompensation defined as past or current ascites, bleeding varices or hepatic encephalopathy. Prior interferon, ribavirin and/or HCV protease inhibitor exposure will be allowed with the exception of cirrhotic with a past history of null response to interferon-based therapy.
* Ability to remain adherent to medications and study protocol as per investigator opinion
* For female subjects, not pregnant, planning or suspected to be pregnant or breast-feeding
* Willing to use acceptable methods of birth control, as defined in protocol
* Active substance use and/or mental health issues will not be exclusionary assuming other criteria are met. This inclusion will be restricted to those stably housed and engaged in harm reduction strategies. Our intent is to evaluate study participants who are representative of our clinical population and consider 'difficult to cure' compared to populations already evaluated in licensing studies
Exclusion Criteria:
* Concomitant use of drugs with contraindication drug interactions with E/C/F/TAF of SOF-LDV
* History of HIV integrase inhibitors or NRTI resistance mutations
* Platelets \<50 x10\^9/L
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02660905
Study Brief:
Protocol Section:
NCT02660905