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Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV

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ClinicalTrials.gov Identifier: NCT01878799
Recruitment Status : Completed
First Posted : June 17, 2013
Results First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C
HIV
Intervention Drug: GS-7977/GS- 5885 FDC
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subjects With HIV and HCV on Antiretroviral Agents Subjects With HIV and HCV Who Are Not on Antiretroviral Agents
Hide Arm/Group Description Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor. Subjects with HIV and HCV not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
Period Title: Overall Study
Started 37 13
Completed 36 13
Not Completed 1 0
Arm/Group Title Subjects With HIV and HCV on Antiretroviral Agents Subjects With HIV and HCV Who Are Not on Antiretroviral Agents Total
Hide Arm/Group Description Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor. Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor. Total of all reporting groups
Overall Number of Baseline Participants 37 13 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 13 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
  86.5%
13
 100.0%
45
  90.0%
>=65 years
5
  13.5%
0
   0.0%
5
  10.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 13 participants 50 participants
Female
7
  18.9%
6
  46.2%
13
  26.0%
Male
30
  81.1%
7
  53.8%
37
  74.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 13 participants 50 participants
Hispanic or Latino
2
   5.4%
0
   0.0%
2
   4.0%
Not Hispanic or Latino
35
  94.6%
13
 100.0%
48
  96.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 13 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
31
  83.8%
10
  76.9%
41
  82.0%
White
6
  16.2%
3
  23.1%
9
  18.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Achieved SVR12 (HCV RNA <LLOQ 12 Weeks After Completion of Treatment)
Hide Description The primary end point was sustained virologic response [plasma HCV RNA level <12 IU/mL by real-time HCV assay (Abbott)] at 12 weeks after treatment completion (SVR12) among all patients enrolled in the study.
Time Frame 12 weeks after completion of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis included all subjects who received at least one dose of study treatment.
Arm/Group Title Subjects With HIV and HCV on Antiretroviral Agents Subjects With HIV and HCV Who Are Not on Antiretroviral Agents
Hide Arm/Group Description:
Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
Overall Number of Participants Analyzed 37 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97
(89 to 100)
100
(75 to 100)
Time Frame On or after the first dose of the study drug up to date of last dose of study drug (12 weeks) plus 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subjects With HIV and HCV on Antiretroviral Agents Subjects With HIV and HCV Who Are Not on Antiretroviral Agents
Hide Arm/Group Description Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor. Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
All-Cause Mortality
Subjects With HIV and HCV on Antiretroviral Agents Subjects With HIV and HCV Who Are Not on Antiretroviral Agents
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Subjects With HIV and HCV on Antiretroviral Agents Subjects With HIV and HCV Who Are Not on Antiretroviral Agents
Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   1/13 (7.69%) 
Infections and infestations     
Pneumonia  1  0/37 (0.00%)  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Subjects With HIV and HCV on Antiretroviral Agents Subjects With HIV and HCV Who Are Not on Antiretroviral Agents
Affected / at Risk (%) Affected / at Risk (%)
Total   36/37 (97.30%)   13/13 (100.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/37 (0.00%)  1/13 (7.69%) 
Constipation  1  0/37 (0.00%)  1/13 (7.69%) 
Diarrhoea  1  2/37 (5.41%)  2/13 (15.38%) 
Gastrooesophageal reflux disease  1  0/37 (0.00%)  1/13 (7.69%) 
Nausea  1  2/37 (5.41%)  1/13 (7.69%) 
General disorders     
Fatigue  1  2/37 (5.41%)  3/13 (23.08%) 
Pain  1  2/37 (5.41%)  3/13 (23.08%) 
Immune system disorders     
Seasonal allergy  1  0/37 (0.00%)  1/13 (7.69%) 
Infections and infestations     
Nasopharyngitis  1  4/37 (10.81%)  1/13 (7.69%) 
Pneumonia  1  0/37 (0.00%)  1/13 (7.69%) 
Tooth infection  1  0/37 (0.00%)  1/13 (7.69%) 
Urinary tract infection  1  2/37 (5.41%)  0/13 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  0/37 (0.00%)  1/13 (7.69%) 
Investigations     
Alanine aminotransferase increased  1  7/37 (18.92%)  2/13 (15.38%) 
Amylase increased  1  13/37 (35.14%)  1/13 (7.69%) 
Aspartate aminotransferase increased  1  9/37 (24.32%)  3/13 (23.08%) 
Blood alkaline phosphatase increased  1  3/37 (8.11%)  0/13 (0.00%) 
Blood bicarbonate abnormal  1  2/37 (5.41%)  1/13 (7.69%) 
Blood bilirubin increased  1  0/37 (0.00%)  2/13 (15.38%) 
Blood cholesterol increased  1  16/37 (43.24%)  5/13 (38.46%) 
Blood creatinine increased  1  6/37 (16.22%)  0/13 (0.00%) 
Hemoglobin decreased  1  4/37 (10.81%)  0/13 (0.00%) 
Lipase increased  1  5/37 (13.51%)  0/13 (0.00%) 
Low density lipoprotein increased  1  9/37 (24.32%)  3/13 (23.08%) 
Neutrophil count decreased  1  8/37 (21.62%)  5/13 (38.46%) 
Platelet count decreased  1  0/37 (0.00%)  1/13 (7.69%) 
White blood cell count decreased  1  2/37 (5.41%)  1/13 (7.69%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/37 (0.00%)  1/13 (7.69%) 
Hypercalcemia  1  2/37 (5.41%)  1/13 (7.69%) 
Hyperglycemia  1  12/37 (32.43%)  9/13 (69.23%) 
Hypernatremia  1  0/37 (0.00%)  2/13 (15.38%) 
Hyperuricemia  1  2/37 (5.41%)  1/13 (7.69%) 
Hypoalbuminemia  1  11/37 (29.73%)  8/13 (61.54%) 
Hypocalcemia  1  0/37 (0.00%)  1/13 (7.69%) 
Hypoglycemia  1  3/37 (8.11%)  1/13 (7.69%) 
Hypokalemia  1  2/37 (5.41%)  1/13 (7.69%) 
Hypomagnesemia  1  0/37 (0.00%)  2/13 (15.38%) 
Hyponatremia  1  2/37 (5.41%)  0/13 (0.00%) 
Hypophosphatemia  1  9/37 (24.32%)  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders     
Flank pain  1  0/37 (0.00%)  1/13 (7.69%) 
Myalgia  1  3/37 (8.11%)  1/13 (7.69%) 
Pain in extremity  1  0/37 (0.00%)  1/13 (7.69%) 
Nervous system disorders     
Headache  1  4/37 (10.81%)  1/13 (7.69%) 
Hypoesthesia  1  0/37 (0.00%)  1/13 (7.69%) 
Somnolence  1  0/37 (0.00%)  1/13 (7.69%) 
Psychiatric disorders     
Anxiety  1  0/37 (0.00%)  1/13 (7.69%) 
Confusional state  1  0/37 (0.00%)  1/13 (7.69%) 
Renal and urinary disorders     
Proteinuria  1  1/37 (2.70%)  1/13 (7.69%) 
Renal disorder  1  0/37 (0.00%)  1/13 (7.69%) 
Reproductive system and breast disorders     
Erectile dysfunction  1  2/37 (5.41%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/37 (0.00%)  1/13 (7.69%) 
Cough  1  0/37 (0.00%)  1/13 (7.69%) 
Dyspnoea  1  0/37 (0.00%)  1/13 (7.69%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  2/37 (5.41%)  0/13 (0.00%) 
Social circumstances     
Bereavement  1  0/37 (0.00%)  1/13 (7.69%) 
Surgical and medical procedures     
Tooth extraction  1  0/37 (0.00%)  1/13 (7.69%) 
Vascular disorders     
Hypertension  1  0/37 (0.00%)  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Shyam Kottilil
Organization: National Institute of Allergy and Infectious Diseases
Phone: +1 301 435 0936
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01878799     History of Changes
Other Study ID Numbers: 130159
13-I-0159
First Submitted: June 14, 2013
First Posted: June 17, 2013
Results First Submitted: March 31, 2016
Results First Posted: September 15, 2016
Last Update Posted: September 15, 2016