Phase III HIV/HCV Co-Infection Daclatasvir (DCV)+ Sofosbuvir (SOF) (ALLY 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02032888
First received: January 9, 2014
Last updated: August 21, 2014
Last verified: June 2014

January 9, 2014
August 21, 2014
February 2014
November 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02032888 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase III HIV/HCV Co-Infection Daclatasvir (DCV)+ Sofosbuvir (SOF)
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)

To study the combination of Daclatasvir and Sofosbuvir for the treatment of HCV/ HIV Coinfection

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
  • Drug: Daclatasvir
    Other Name: BMS-790052
  • Drug: Sofosbuvir
  • 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
    Interventions:
    • Drug: Daclatasvir
    • 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
    Interventions:
    • Drug: Daclatasvir
    • Drug: Sofosbuvir
  • Experimental: Arm 3: Cohort 2-Treatment Experienced-12 weeks
    Daclatasvir 30, 60 or 90 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
    Interventions:
    • Drug: Daclatasvir
    • Drug: Sofosbuvir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
January 2015
November 2014   (final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02032888
AI444-216
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP