Clinical trial NCT01565889: Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hepatitis C
HIV
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics of sofosbuvir (GS-7977; PSI-7977) and its metabolites in participants with HIV and hepatitis C virus (HCV) coinfection. Part B, the Phase 2 treatment study, will investigate the efficacy and safety of sofosbuvir, pegylated interferon alpha (PEG) and ribavirin (RBV) in participants with HIV/HCV coinfection.


Eligibility 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

Primary outcomes:
measure: Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
timeFrame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
measure: Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
timeFrame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
measure: Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
timeFrame: Posttreatment Weeks 4 and 24
Other outcomes:
measure: Part B: On-treatment HCV RNA
timeFrame: Up to 8 weeks
measure: Part B: On-treatment HIV RNA
timeFrame: Up to 8 weeks
Locations:
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Gilead Sciences
name: Anuj Gaggar, MD/PhD
role: STUDY_DIRECTOR
References:
citation: Rodriguez-Torres M, Gaggar A, Shen G, Kirby B, Svarovskaia E, Brainard D, Symonds WT, McHutchison JG, Gonzalez M, Rodriguez-Orengo J. Sofosbuvir for chronic hepatitis C virus infection genotype 1-4 in patients coinfected with HIV. J Acquir Immune Defic Syndr. 2015 Apr 15;68(5):543-9. doi: 10.1097/QAI.0000000000000516.