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Part A: Drug Interaction Study of GS-7977 and Antiretroviral Therapy(ART) Combinations in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) Co-infected Patients. Part B: Phase 2, Open-Label Study to Investigate Efficacy and Safety of GS-7977 for 12 Weeks in HIV/HCV Co-infected Patients.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01565889
First received: March 27, 2012
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

This study consists of 2 parts, Part A and Part B. Part A, the Drug Interaction/Early Viral Kinetic Study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics and pharmacokinetics of GS-7977 and its metabolites in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) Co-infected Patients. Part B, the Phase 2 Treatment Study, will investigate the efficacy and safety of GS-7977, Peginterferon Alfa 2a and Ribavirin in HIV/HCV co-infected subjects.


Condition Intervention Phase
Hepatitis C
HIV
 Drug: GS-7977
Drug: Efavirenz (EFV)
Drug: Tenofovir (TDF)
Drug: Emtricitabine (FTC)
Drug: Atazanavir/ritonavir (ATV/r)
Drug: Zidovudine (ZDV)
Drug: Lamivudine (3TC)
Drug: Darunavir/ritonavir (DRV/r)
Drug: Raltegravir (RAL)
Drug: Ribavirin (RBV)
Drug: Peginterferon Alfa 2a (PEG)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Part A: Drug Interaction Study Between GS-7977 and Antiretroviral Therapy (ARV) Combinations of Efavirenz, Tenofovir and Emtricitabine; Efavirenz, Zidovudine and Lamivudine; Atazanavir/Ritonavir, Tenofovir and Emtricitabine; Darunavir/Ritonavir, Tenofovir and Emtricitabine; Raltegravir, Tenofovir and Emtricitabine in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) Co-infected Patients. Part B: A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naïve HIV/HCV Co-infected Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Part A: Evaluate whether GS-7977 will significantly influence the PK parameters of Antiretroviral Therapy (ART)in healthy HIV/HCV co-infected subjects. [ Time Frame: Part A: 7 days ] [ Designated as safety issue: Yes ]
    Part A: Evaluate whether GS-7977 will significantly influence the PK parameters of Atazanavir/ritonavir (ATV/r), Efavirenz (EFV), Tenofovir (TDF), Emtricitabine(FTC),Zidovudine (ZDV), Lamivudine (3TC), Darunavir/ritonavir (DRV/r) or Raltegravir (RAL) in healthy HIV/HCV co-infected subjects.

  • Part B: Efficacy of GS-7977 + Peginterferon Alfa 2a (PEG) + Ribavirin (RBV) [ Time Frame: Part B: 12 weeks after discontinuation of therapy ] [ Designated as safety issue: No ]
    Part B: To determine the efficacy of treatment with GS-7977 + PEG + RBV as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12).

  • Part B: To evaluate the safety and tolerability of GS-7977 + PEG + RBV as assessed by review of the accumulated safety data, including HIV-RNA and CD4 T-cell percent. [ Time Frame: Part B: Safety and Tolerability on treatment and 30 days post last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A: Cohort 1
GS-7977 (400 mg) QD + Efavirenz (600 mg) QD + Tenofovir (300 mg) QD + Emtricitabine (200 mg) QD
 Drug: GS-7977 Drug: Efavirenz (EFV) Drug: Tenofovir (TDF) Drug: Emtricitabine (FTC)
Experimental: Part A: Cohort 2
GS-7977 (400 mg) QD + Efavirenz (600 mg) QD + Zidovudine (300 mg) BID + Lamivudine (150 mg) BID.
 Drug: GS-7977 Drug: Efavirenz (EFV) Drug: Zidovudine (ZDV) Drug: Lamivudine (3TC)
Experimental: Part A: Cohort 3
GS-7977 (400 mg) QD + Atazanavir/ritonavir (400 mg/100 mg) QD + Tenofovir (300 mg) QD + Emtricitabine (200 mg) QD.
 Drug: GS-7977 Drug: Tenofovir (TDF) Drug: Emtricitabine (FTC) Drug: Atazanavir/ritonavir (ATV/r)
Experimental: Part A: Cohort 4
GS-7977 (400 mg) Q + Darunavir/ritonavir (800 mg/100 mg) QD + Tenofovir (300 mg) QD + Emtricitabine (200 mg) QD
 Drug: GS-7977 Drug: Tenofovir (TDF) Drug: Emtricitabine (FTC) Drug: Darunavir/ritonavir (DRV/r)
Experimental: Part A: Cohort 5
GS-7977 (400 mg) QD + Raltegravir (400 mg) BID + Tenofovir (300 mg) QD + Emtricitabine (200 mg) QD
 Drug: GS-7977 Drug: Tenofovir (TDF) Drug: Emtricitabine (FTC) Drug: Raltegravir (RAL)
Experimental: Part B
GS-7977 (400 mg QD) + Ribavirin (wight based dosing 1000 - 1200 mg) + Peginterferon Alfa 2a (180 μg/week).
 Drug: GS-7977 Drug: Ribavirin (RBV) Drug: Peginterferon Alfa 2a (PEG)

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy according to medical history and physical examination with exception of HCV and HIV diagnoses
  • Confirmation of Chronic HCV infection
  • Confirmation of Chronic HIV-1 infection
  • On a stable protocol approved HIV antiretroviral (ARV) regimen with undetectable HIV-RNA
  • Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
  • Subjects must be naive to treatment for chronic HCV infection

Exclusion Criteria:

  • Known or suspected cirrhosis
  • History of any other clinically significant chronic liver disease
  • A history consistent with decompensated liver disease.
  • Use of any prohibited medications as defined by the protocol
  • Pregnant or nursing female or male with pregnant female partner
  • Contraindication to PEG or RBV therapy (for Part B)
  • Clinically relevant drug or alcohol abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565889

Locations
Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Anuj Gaggar, MD/PhD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01565889     History of Changes
Other Study ID Numbers: P7977-1910
Study First Received: March 27, 2012
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis C
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
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
Zidovudine
Lamivudine
Ritonavir
Tenofovir
Tenofovir disoproxil
Efavirenz
Peginterferon alfa-2a
Interferon-alpha
Emtricitabine

ClinicalTrials.gov processed this record on March 03, 2013