A Phase 3, Open-label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
![](https://webarchive.library.unt.edu/web/20130305095855im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
This is an Open-label Phase 3 study in subjects with chronic Genotype 1, 2 and 3 HCV-infection who are co-infected with HIV-1. A total of 230 (115 GT 2/3 and 115 GT1) HIV-1/HCV co-infected subjects will be enrolled into one of 3 treatment regimens depending on their genotype and prior HCV treatment history.
Subjects will be treated with oral GS-7977 400 mg QD plus weight based RBV (1000 or 1200 mg/day) BID for 12 weeks or 24 weeks. The study population will include Genotype 1, 2, and 3 treatment naive subjects (including IFN ineligible) and Genotype 2 and 3 treatment experienced subjects who have failed prior therapy with PEG/RBV. Approximately 20% of the subjects enrolled will have evidence of compensated cirrhosis at Screening.
Condition | Intervention | Phase |
---|---|---|
Hepatitis C, Human Immunodeficiency Virus |
Drug: GS-7977 + Ribavirin |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | A Phase 3, Open-label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects |
- Efficacy of GS-7977 + Ribavirin (RBV) [ Time Frame: 12 weeks after discontinuation of therapy ] [ Designated as safety issue: No ]To determine the efficacy of treatment with GS-7977 + ribavirin (RBV) by proportion of subjects with sustained viral response 12 weeks (SVR 12) after discontinuation of therapy
- Safety and Tolerability of GS-7977 + Ribavirin (RBV) measured by review of accumulated safety data. [ Time Frame: Safety and tolerability on treatment and 30 days post last dose ] [ Designated as safety issue: Yes ]To evaluate the safety and tolerability of GS-7977 + Ribavirin(RBV) as assessed by review of the accumulated safety data
- Sustained Viral Response at 4 weeks and 24 weeks (SVR4 and SVR 24) [ Time Frame: 4 and 24 weeks after discontinuation of therapy ] [ Designated as safety issue: No ]To determine the proportion of subjects who attain sustained viral response (SVR) at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
- Kinetics of circulating HCV RNA during and after treatment discontinuation [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]On treatment and post treatment HCV RNA levels over time will be used to characterize the kinetics of circulating HCV RNA during and after treatment discontinuation
- Emergence of Viral Resistance measured by patients with viral resistance. [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]To evaluate the emergence of viral resistance to GS-7977 during treatment and after treatment discontinuation
Estimated Enrollment: | 230 |
Study Start Date: | July 2012 |
Estimated Study Completion Date: | February 2014 |
Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: GS-7977 + Ribavirin
230 HIV-1/HCV co-infected subjects will be enrolled and treated with oral GS-7977 400 mg QD plus weight based RBV (1000 or 1200 mg/day) BID for 12 or 24 weeks based on genotype and treatment experience.
|
Drug: GS-7977 + Ribavirin
GS-7977: 400mg Ribavirin (RBV): 1000 or 1200 mg/day weight based 12 or 24 week duration
|
![](https://webarchive.library.unt.edu/web/20130305095855im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- Willing and able to provide written informed consent
- Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection
- HCV RNA > 1 x 104 IU/mL at Screening
- Infection with HCV genotype 1, 2 or 3 as determined at Screening
- HIV-1 infection confirmed with positive ELISA or Western blot at Screening
- The subject's medical records must be sufficient to be categorized on IFN eligibility or prior treatment history with PEG/RBV.
- Confirmation of chronic HCV infection
- Ability to determine presence/absence of cirrhosis.
HIV antiretroviral therapy (ARV) criteria of one of the following:
- ARV untreated with a CD4 T-cell count >500 cells/mm3
- On a stable, protocol-approved, ARV for >8 weeks prior to Screening with a CD4 T-cell count >200 cells/mm3 and a documented undetectable plasma HIV-1 RNA level for ≥ 8 weeks preceding the Screening visit
- Approved HIV antiretroviral medications based on drug interaction studies
- Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
- Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV
- Male subjects who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV
- Subject must be of generally good health as determined by the Investigator.
- Liver imaging within 6 months of Baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- Non-genotype 1/2/3 or mixed genotype at Screening
- Genotype 1 with prior treatment for HCV
- Poor control with ARV regimen
- Prior exposure to a direct-acting antiviral targeting the HCV NS5B polymerase
- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
- A new AIDS-defining condition diagnosed within 30 days prior to screening
- Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to Baseline
- Infection with hepatitis B virus (HBV)
- Contraindication to RBV therapy
- Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day)
- History of solid organ transplantation or malignancy diagnosed or treated within 5 years
- Current or prior history of clinical hepatic decompensation or other significant gastrointestinal disorder
![](https://webarchive.library.unt.edu/web/20130305095855im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20130305095855im_/http://clinicaltrials.gov/ct2/html/images/frame/plus.gif)
Study Director: | Anuj Gaggar | Gilead Sciences |
![](https://webarchive.library.unt.edu/web/20130305095855im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01667731 History of Changes |
Other Study ID Numbers: | GS-US-334-0123 |
Study First Received: | August 9, 2012 |
Last Updated: | February 14, 2013 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
Hepatitis C Chronic HCV |
HIV Human Immunodeficiency Virus Co-Infected |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis Hepatitis A Hepatitis C Immunologic Deficiency Syndromes Virus Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections Ribavirin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on March 03, 2013