Hepatitis CPhase 1/2NCT01565889

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.

A Phase 1/2 study testing SOF, EFV/FTC/TDF and EFV in people with Hepatitis C and HIV, run by Gilead Sciences at 1 site in Puerto Rico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Hepatitis C, HIV
What is being tested?: SOF, EFV/FTC/TDF and EFV
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 sitePuerto Rico
Study dates: Mar 2012to Nov 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Puerto Rico1 site

Fundacion de Investigacion de Diego
San Juan, 00927

Other trials in Puerto Rico

About this study

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.

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.

Conditions: Hepatitis C, HIV
Being tested: SOF, EFV/FTC/TDF, EFV, ZDV/3TC, ATV
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SOFDrug
Also called Sovaldi®, GS-7977, PSI-7977
Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
EFV/FTC/TDFDrug
Also called Atripla®
Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily
EFVDrug
Also called Sustiva®
Efavirenz (EFV) 600 mg tablet administered orally once daily
ZDV/3TCDrug
Also called Combivir®
Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily
ATVDrug
Atazanavir (ATV) 400 mg tablet administered orally once daily
RitonavirDrug
Ritonavir (RTV) 100 mg tablet administered orally once daily
FTC/TDFDrug
Also called Truvada®
FTC/TDF (200/300 mg) FDC tablet administered orally once daily
DRVDrug
Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily
RALDrug
Raltegravir (RAL) 400 mg administered administered orally twice daily
PEGDrug
Also called Pegasys®
Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection
RBVDrug
Also called Ribasphere®
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Study groups in NCT01565889
Study group	Role	What they receive
Part A: SOF+EFV/FTC/TDF (Cohort 1)	Experimental	Participants with a prestudy regimen of EFV/FTC/TDF will receive SOF+EFV/FTC/TDF FDC for 7 days, followed by EFV/FTC/TDF FDC (or EFV+FTC/TDF) for 7 days, coadministered once daily in the evening under fasting conditions. Receives: Drug: SOF; Drug: EFV/FTC/TDF
Part A: SOF+EFV+ZDV/3TC (Cohort 2)	Experimental	Participants with a prestudy regimen of EFV+ZDV/3TC will receive SOF+EFV+ZDV/3TC for 7 days followed by EFV+ZDV/3TC for 7 days. Sofosbuvir and EFV will be administered once daily in the evening under fasting conditions; ZDV/3TC will be administered twice daily, in the morning without regard to food and in the evening on an empty stomach. Receives: Drug: SOF; Drug: EFV; Drug: ZDV/3TC
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)	Experimental	Participants with a prestudy regimen of RTV+ATV+FTC/TDF will receive SOF+RTV+ATV+FTC/TDF for 7 days followed by RTV+ATV+FTC/TDF for 7 days coadministered once daily in the morning with food. Receives: Drug: SOF; Drug: ATV; Drug: Ritonavir; Drug: FTC/TDF
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)	Experimental	Participants with a prestudy regimen of RTV+DRV+FTC/TDF will receive SOF+RTV+DRV+FTC/TDF for 7 days followed by RTV+DRV+FTC/TDF for 7 days coadministered once daily in the morning with food. Receives: Drug: SOF; Drug: Ritonavir; Drug: FTC/TDF; Drug: DRV
Part A: SOF+RAL+FTC/TDF (Cohort 5)	Experimental	Participants with a prestudy regimen of RAL+FTC/TDF will receive SOF+RAL+FTC/TDF for 7 days followed by RAL+FTC/TDF for 7 days. Sofosbuvir and FTC/TDF will be administered once daily in the morning with food; RAL will be administered twice daily, in the morning with food and in the evening without regard to food. Receives: Drug: SOF; Drug: FTC/TDF; Drug: RAL
Part B: SOF+PEG+RBV	Experimental	Participants will receive SOF+PEG+RBV for 12 weeks. Receives: Drug: SOF; Drug: PEG; Drug: RBV

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
Data for this outcome measure were collected for participants in Part A only.
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
Cmax: maximum observed concentration of drug in plasma.
Data for this outcome measure were collected for participants in Part A only.
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Data for this outcome measure were collected for participants in Part B only.
Measured: Posttreatment Week 12
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants discontinuing any study drug due to an adverse event was summarized.
Measured: Up to 12 weeks

Secondary outcomes (2)

Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Data for this outcome measure were collected for participants in Part B only.
Measured: Posttreatment Weeks 4 and 24
Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) on treatment after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
Data for this outcome measure were collected for participants in Part B only.
Measured: Posttreatment Weeks 4 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Nov 2013

First posted29 Mar 2012 (estimated)
Study startMar 2012
Primary completionAug 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01565889
Sponsor's protocol ID: P7977-1910
Status last verified: Sep 2014
First submitted: 27 Mar 2012
Last updated: 1 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 25622055

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01565889
Acronym / sponsor ID: P7977-1910
Conditions: Hepatitis C, HIV
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Aug 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 29 Mar 2012 (estimated)
Results: Posted 1 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Part A: SOF+EFV/FTC/TDF (Cohort 1)	Experimental	Drug: SOF, Drug: EFV/FTC/TDFParticipants with a prestudy regimen of EFV/FTC/TDF will receive SOF+EFV/FTC/TDF FDC for 7 days, followed by EFV/FTC/TDF FDC (or EFV+FTC/TDF) for 7 days, coadministered once daily in the evening under fasting conditions.
Part A: SOF+EFV+ZDV/3TC (Cohort 2)	Experimental	Drug: SOF, Drug: EFV, Drug: ZDV/3TCParticipants with a prestudy regimen of EFV+ZDV/3TC will receive SOF+EFV+ZDV/3TC for 7 days followed by EFV+ZDV/3TC for 7 days. Sofosbuvir and EFV will be administered once daily in the evening under fasting conditions; ZDV/3TC will be administered twice daily, in the morning without regard to food and in the evening on an empty stomach.
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)	Experimental	Drug: SOF, Drug: ATV, Drug: Ritonavir, Drug: FTC/TDFParticipants with a prestudy regimen of RTV+ATV+FTC/TDF will receive SOF+RTV+ATV+FTC/TDF for 7 days followed by RTV+ATV+FTC/TDF for 7 days coadministered once daily in the morning with food.
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)	Experimental	Drug: SOF, Drug: Ritonavir, Drug: FTC/TDF, Drug: DRVParticipants with a prestudy regimen of RTV+DRV+FTC/TDF will receive SOF+RTV+DRV+FTC/TDF for 7 days followed by RTV+DRV+FTC/TDF for 7 days coadministered once daily in the morning with food.
Part A: SOF+RAL+FTC/TDF (Cohort 5)	Experimental	Drug: SOF, Drug: FTC/TDF, Drug: RALParticipants with a prestudy regimen of RAL+FTC/TDF will receive SOF+RAL+FTC/TDF for 7 days followed by RAL+FTC/TDF for 7 days. Sofosbuvir and FTC/TDF will be administered once daily in the morning with food; RAL will be administered twice daily, in the morning with food and in the evening without regard to food.
Part B: SOF+PEG+RBV	Experimental	Drug: SOF, Drug: PEG, Drug: RBVParticipants will receive SOF+PEG+RBV for 12 weeks.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SOFAlso: Sovaldi®, GS-7977, PSI-7977Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily	Drug	Part A: SOF+EFV+ZDV/3TC (Cohort 2), Part A: SOF+EFV/FTC/TDF (Cohort 1), Part A: SOF+RAL+FTC/TDF (Cohort 5), Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3), Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4), Part B: SOF+PEG+RBV
EFV/FTC/TDFAlso: Atripla®Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily	Drug	Part A: SOF+EFV/FTC/TDF (Cohort 1)
EFVAlso: Sustiva®Efavirenz (EFV) 600 mg tablet administered orally once daily	Drug	Part A: SOF+EFV+ZDV/3TC (Cohort 2)
ZDV/3TCAlso: Combivir®Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily	Drug	Part A: SOF+EFV+ZDV/3TC (Cohort 2)
ATVAtazanavir (ATV) 400 mg tablet administered orally once daily	Drug	Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
RitonavirRitonavir (RTV) 100 mg tablet administered orally once daily	Drug	Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3), Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
FTC/TDFAlso: Truvada®FTC/TDF (200/300 mg) FDC tablet administered orally once daily	Drug	Part A: SOF+RAL+FTC/TDF (Cohort 5), Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3), Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
DRVDarunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily	Drug	Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
RALRaltegravir (RAL) 400 mg administered administered orally twice daily	Drug	Part A: SOF+RAL+FTC/TDF (Cohort 5)
PEGAlso: Pegasys®Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection	Drug	Part B: SOF+PEG+RBV
RBVAlso: Ribasphere®Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)	Drug	Part B: SOF+PEG+RBV

Primary outcome

Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Data for this outcome measure were collected for participants in Part A only.
Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
Cmax: maximum observed concentration of drug in plasma. Data for this outcome measure were collected for participants in Part A only.
Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Time frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. Data for this outcome measure were collected for participants in Part B only.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Time frame: Up to 12 weeks
The percentage of participants discontinuing any study drug due to an adverse event was summarized.

2 secondary outcomes

Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time frame: Posttreatment Weeks 4 and 24
Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Time frame: Posttreatment Weeks 4 and 24

Results and safety

Results posted to the registry on 1 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: SOF+EFV/FTC/TDF (Cohort 1)	12	11
Part A: SOF+EFV+ZDV/3TC (Cohort 2)	4	4
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)	8	8
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)	7	7
Part A: SOF+RAL+FTC/TDF (Cohort 5)	7	7
Part B: SOF+PEG+RBV	0	0

Primary outcome: Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7

Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Part A: SOF+EFV/FTC/TDF (Cohort 1) n = 8	Part A: SOF+EFV+ZDV/3TC (Cohort 2) n = 4	Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) n = 8	Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) n = 7	Part A: SOF+RAL+FTC/TDF (Cohort 5) n = 7
Pharmacokinetics of SOF (AUCtau at Day 7)	867.5 (460.34)	627.6 (315.87)	2269.4 (567.58)	1421.5 (415.10)	1687.1 (573.42)
Pharmacokinetics of EFV (AUCtau at Day 7)	95094.4 (71267.91)	53770.7 (39263.90)	NA (NA)	NA (NA)	NA (NA)
Pharmacokinetics of TFV (AUCtau at Day 7)	2351.2 (960.74)	NA (NA)	3793.0 (835.11)	3996.8 (1665.17)	2657.1 (751.31)
Pharmacokinetics of FTC (AUCtau at Day 7)	10144.8 (2832.23)	NA (NA)	11564.9 (1739.26)	13091.2 (4093.09)	10622.8 (815.24)

Population analysed: Pharmacokinetics (PK) Analysis Set: participants with evaluable PK profiles who enrolled into Part A of the study and received study drug. Participants in the PK Analysis Set with available data were included.

Primary outcome: Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7

Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose. Mean (Standard Deviation). Unit: ng/mL

Measure	Part A: SOF+EFV/FTC/TDF (Cohort 1) n = 8	Part A: SOF+EFV+ZDV/3TC (Cohort 2) n = 4	Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) n = 8	Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) n = 7	Part A: SOF+RAL+FTC/TDF (Cohort 5) n = 7
Pharmacokinetics of SOF (Cmax at Day 7)	635.0 (344.19)	285.1 (62.28)	1228.9 (474.93)	828.2 (351.41)	1189.2 (483.83)
Pharmacokinetics of EFV (Cmax at Day 7)	5423.8 (3283.86)	3469.5 (1707.54)	NA (NA)	NA (NA)	NA (NA)
Pharmacokinetics of TFV (Cmax at Day 7)	372.5 (208.71)	NA (NA)	519.8 (119.89)	441.8 (134.13)	388.1 (118.53)
Pharmacokinetics of FTC (Cmax at Day 7)	1533.1 (829.88)	NA (NA)	1797.9 (232.54)	1808.2 (530.10)	2079.5 (434.32)

Population analysed: Participants in the PK Analysis Set with available data were included.

Primary outcome: Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)

Time frame: Posttreatment Week 12. Number. Unit: percentage of participants

Measure	Part B: SOF+PEG+RBV n = 23
Value	91.3

Population analysed: Part B Full Analysis Set: participants enrolled into Part B of the study and dosed with at least 1 dose of study drug(s)

Primary outcome: Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

Time frame: Up to 12 weeks. Number. Unit: percentage of participants

Measure	Part A: SOF+EFV/FTC/TDF (Cohort 1) n = 8	Part A: SOF+EFV+ZDV/3TC (Cohort 2) n = 4	Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) n = 8	Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) n = 7	Part A: SOF+RAL+FTC/TDF (Cohort 5) n = 7	Part B: SOF+PEG+RBV n = 23
Value	0	0	0	0	0	8.7

Population analysed: Safety Analysis Set: participants who received at least 1 dose of study drug(s)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 weeks plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: SOF+EFV/FTC/TDF (Cohort 1)	0 of 12 (0%)	2 of 12 (16.7%)	Not reported
Part A: SOF+EFV+ZDV/3TC (Cohort 2)	0 of 4 (0%)	0 of 4 (0%)	Not reported
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)	0 of 8 (0%)	0 of 8 (0%)	Not reported
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)	0 of 7 (0%)	2 of 7 (28.6%)	Not reported
Part A: SOF+RAL+FTC/TDF (Cohort 5)	0 of 7 (0%)	1 of 7 (14.3%)	Not reported
Part B: SOF+PEG+RBV	0 of 23 (0%)	16 of 23 (69.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25622055Rodriguez-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.

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HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anuj Gaggar, MD/PhD study director

Gilead Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SOF, EFV/FTC/TDF and EFV in people with Hepatitis C and HIV, run by Gilead Sciences at 1 site in Puerto Rico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7 (time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01565889, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.