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Trial record 31 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection

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ClinicalTrials.gov Identifier: NCT02457611
Recruitment Status : Completed
First Posted : May 29, 2015
Results First Posted : February 28, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Infection With HIV Co-Infection
Intervention Drug: LDV/SOF
Enrollment 26
Recruitment Details Participants were enrolled at study sites in Germany and the United Kingdom. The first participant was screened on 11 June 2015. The last study visit occurred on 8 January 2016.
Pre-assignment Details 34 participants were screened.
Arm/Group Title LDV/SOF
Hide Arm/Group Description Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks
Period Title: Overall Study
Started 26
Completed 23
Not Completed 3
Reason Not Completed
Lost to Follow-up             3
Arm/Group Title LDV/SOF
Hide Arm/Group Description LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
41  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
0
   0.0%
Male
26
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Black or African American
1
   3.8%
White
24
  92.3%
Asian
1
   3.8%
Hispanic or Latino
1
   3.8%
Not Hispanic or Latino
22
  84.6%
Not Disclosed
3
  11.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
United Kingdom
11
  42.3%
Germany
15
  57.7%
IL28b Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
CC
12
  46.2%
CT
11
  42.3%
TT
3
  11.5%
HCV Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Genotype 1a
19
  73.1%
Genotype 4
7
  26.9%
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 26 participants
5.4  (1.60)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
< 800,000 IU/mL
14
  53.8%
>= 800,000 IU/mL
12
  46.2%
CD4 Counts  
Mean (Standard Deviation)
Unit of measure:  cells/uL
Number Analyzed 26 participants
675  (251.3)
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants with genotype 1 or 4 HCV infection who were enrolled into the study and received at least 1 dose of study drug
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
76.9
(56.4 to 91.0)
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame Up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: percentage of participants
0
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)
Hide Description SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.6
(65.1 to 95.6)
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ on Treatment
Hide Description [Not Specified]
Time Frame Weeks 2, 4, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
73.1
(52.2 to 88.4)
Week 4
88.5
(69.8 to 97.6)
Week 6
96.2
(80.4 to 99.9)
5.Secondary Outcome
Title Change From Baseline in HCV RNA at Weeks 2, 4, and 6
Hide Description [Not Specified]
Time Frame Baseline; Weeks 2, 4, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 2 Number Analyzed 26 participants
-4.01  (1.497)
Change at Week 4 Number Analyzed 25 participants
-4.16  (1.583)
Change at Week 6 Number Analyzed 25 participants
-4.17  (1.583)
6.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

Virologic failure was defined as:

  • On-treatment virologic failure

    • confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),
    • confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),
    • HCV RNA persistently ≥ LLOQ through end of treatment (ie, nonresponse)
  • Relapse

    • HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
Time Frame Up to Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: percentage of participants
15.4
7.Secondary Outcome
Title Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.
Hide Description Participants with HIV virologic rebound was defined as participants with at least two HIV RNA ≥ 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates.
Time Frame Day 1; Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
8.Secondary Outcome
Title Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4
Hide Description [Not Specified]
Time Frame Weeks 2, 4, 6, and Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set who had HIV-1 RNA < 50 copies/mL at Baseline were analyzed.
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
Overall Number of Participants Analyzed 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
100.0
(83.9 to 100.0)
Week 4
100.0
(83.9 to 100.0)
Week 6
95.2
(76.2 to 99.9)
Posttreatment Week 4
100.0
(83.9 to 100.0)
9.Secondary Outcome
Title Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4
Hide Description [Not Specified]
Time Frame Baseline; Week 6; Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: percent change
Change at Week 6 Number Analyzed 24 participants
-0.3  (4.91)
Change at Posttreatment Week 4 Number Analyzed 23 participants
0.4  (4.08)
Time Frame Up to 6 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title LDV/SOF
Hide Arm/Group Description LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
All-Cause Mortality
LDV/SOF
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF
Affected / at Risk (%)
Total   1/26 (3.85%) 
General disorders   
Pyrexia  1  1/26 (3.85%) 
Nervous system disorders   
Loss of consciousness  1  1/26 (3.85%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia aspiration  1  1/26 (3.85%) 
Vascular disorders   
Thrombophlebitis  1  1/26 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF
Affected / at Risk (%)
Total   20/26 (76.92%) 
Gastrointestinal disorders   
Diarrhoea  1  3/26 (11.54%) 
Nausea  1  3/26 (11.54%) 
Toothache  1  2/26 (7.69%) 
General disorders   
Fatigue  1  7/26 (26.92%) 
Infections and infestations   
Nasopharyngitis  1  7/26 (26.92%) 
Oral herpes  1  2/26 (7.69%) 
Syphilis  1  2/26 (7.69%) 
Nervous system disorders   
Headache  1  6/26 (23.08%) 
Psychiatric disorders   
Insomnia  1  3/26 (11.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
There were no limitations affecting the analysis or results.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
EMail: ClinicalTrialDisclosures@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02457611     History of Changes
Other Study ID Numbers: GS-US-337-1612
2014-004812-12 ( EudraCT Number )
First Submitted: May 27, 2015
First Posted: May 29, 2015
Results First Submitted: January 6, 2017
Results First Posted: February 28, 2017
Last Update Posted: November 16, 2018