This study is not yet open for participant recruitment.
Verified January 2014 by Bristol-Myers Squibb
Sponsor: Bristol-Myers Squibb
Information provided by (Responsible Party): Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032888
First received: January 9, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
Purpose
To study the combination of Daclatasvir and Sofosbuvir for the treatment of HCV/ HIV Coinfection
| Condition | Intervention | Phase |
|---|---|---|
| Hepatitis C | Drug: Daclatasvir Drug: Sofosbuvir | Phase 3 |
Study Type: Interventional
Study Design:
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title:
A Phase 3 Evaluation of Daclatasvir Plus Sofosbuvir in Treatment-naïve and Treatment-experienced Chronic Hepatitis C (Genotype 1, 2, 3, 4, 5, or 6) Subjects Coinfected With Human Immunodeficiency Virus (HIV)
Resource links provided by NLM:
Genetics Home Reference related topics: complement factor I deficiency
MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis C
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Proportion of treatment-naive subjects with sustained virologic response 12 (SVR12) [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]
SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 for the treatment-naive HCV genotype 1 subjects coinfected with HIV on the DCV+SOF 12-week regimen
Secondary Outcome Measures:
- Proportion of treatment-naive subjects with SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]
SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 for the treatment-naive HCV genotype 1 subjects coinfected with HIV on the DCV+SOF 8 -week regimen
- Proportion of treatment-experienced HCV subjects with SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]
SVR12 defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 for the treatment-experienced HCV genotype 1 subjects coinfected with HIV on the DCV+SOF 12-week regimen
- Proportion of HIV/HCV coinfected subjects, in each treatment arm, with SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]
SVR12 defined as HCV RNA < LLOQ TD or TND at follow-up Week 12 without regard to infecting HCV genotype
- Safety measured by deaths and the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), Grade 3/4 AEs, and Grade 3/4 laboratory abnormalities [ Time Frame: Up to EOT (Approximately 8/12 weeks depending on treatment regimen) + 7 days ] [ Designated as safety issue: Yes ]
EOT = End of treatment
- The proportion of subjects coinfected with HIV, in each treatment arm, who achieve HCV RNA < LLOQ-TD/TND [ Time Frame: At Weeks: 1, 2, 4, 6, 8 and 12 (for subjects in the 12-week arm) and EOT; post-treatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
- The proportion of subjects coinfected with HIV, in each treatment arm, who achieve HCV RNA < LLOQ TND [ Time Frame: At Weeks: 1, 2, 4, 6, 8 and 12 (for subjects in the 12-week arm) and EOT ] [ Designated as safety issue: No ]
- The proportion of HIV/HCV coinfected subjects, in each treatment arm, with CC or non-CC genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNPs) who achieve SVR12 [ Time Frame: Post treatment Week 12 ] [ Designated as safety issue: No ]
Estimated Enrollment: 200
Study Start Date: February 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1: Cohort 1a-Treatment-naive-12 weeks Daclatasvir 30, 60 or 90 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks | Drug: Daclatasvir Other Name: BMS-790052 Drug: Sofosbuvir |
| Experimental: Arm 2: Cohort 1b-Treatment-naive-8 weeks Daclatasvir 30, 60 or 90 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 8 weeks | Drug: Daclatasvir Other Name: BMS-790052 Drug: Sofosbuvir |
| Experimental: Arm 3: Cohort 2-Treatment Experineced-12 weeks Daclatasvir 30, 60 or 90 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks | Drug: Daclatasvir Other Name: BMS-790052 Drug: Sofosbuvir |
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
- Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
- Subjects chronically infected with HCV genotype 1, 2, 3, 4, 5 or 6, as documented by positive HCV RNA at screening
- HCV-Treatment-naive subjects
- HCV treatment-experienced subjects are eligible. All permitted prior anti-HCV therapies must be discontinued or completed at least 12 weeks prior to screening
- Subjects must have an HCV RNA ≥ 10,000 IU/mL at Screening
- Subjects must have HIV-1 infection
Exclusion Criteria:
- Presence of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 weeks prior to study entry (AIDS-defining opportunistic infections as defined by the CDC)
- Subjects infected with HIV-2
- Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
- Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
- Evidence of decompensated liver disease including, but not limited to, radiologic criteria,a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02032888
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director:
Bristol-Myers Squibb Bristol-Myers Squibb
More Information
No publications provided
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032888 History of Changes
Other Study ID Numbers: AI444-216
Study First Received: January 9, 2014
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration
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