Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment (Co-STARs)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02707601 |
Recruitment Status :
Completed
First Posted : March 14, 2016
Results First Posted : October 9, 2018
Last Update Posted : November 14, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
HIV-1 Infection HCV Infection |
Interventions |
Drug: E/C/F/TAF Drug: F/R/TAF Drug: LDV/SOF |
Enrollment | 150 |
Recruitment Details | Participants were enrolled at study sites in the United States. The first participant was screened on 01 April 2016. The last study visit occurred on 29 September 2017. |
Pre-assignment Details | 259 participants were screened. |
Arm/Group Title | E/C/F/TAF + LDV/SOF | F/R/TAF + LDV/SOF |
---|---|---|
![]() |
Part 1: Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). |
Part 1: Participants received emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). |
Period Title: Overall Study | ||
Started | 76 | 74 |
Completed | 72 | 70 |
Not Completed | 4 | 4 |
Reason Not Completed | ||
Death | 0 | 1 |
Lack of Efficacy | 0 | 1 |
Investigator's Discretion | 1 | 0 |
Withdrew Consent | 0 | 1 |
Lost to Follow-up | 1 | 1 |
Participants Randomized but Not Treated | 2 | 0 |
Arm/Group Title | E/C/F/TAF + LDV/SOF | F/R/TAF + LDV/SOF | Total | |
---|---|---|---|---|
![]() |
Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). |
Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study. Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). |
Total of all reporting groups | |
Overall Number of Baseline Participants | 74 | 74 | 148 | |
![]() |
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug (E/C/F/TAF, F/R/TAF, or LDV/SOF).
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 74 participants | 74 participants | 148 participants | |
51 (9.5) | 52 (9.9) | 51 (9.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 74 participants | 74 participants | 148 participants | |
Female |
16 21.6%
|
22 29.7%
|
38 25.7%
|
|
Male |
58 78.4%
|
52 70.3%
|
110 74.3%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 74 participants | 74 participants | 148 participants | |
Hispanic or Latino |
13 17.6%
|
14 18.9%
|
27 18.2%
|
|
Not Hispanic or Latino |
61 82.4%
|
59 79.7%
|
120 81.1%
|
|
Unknown or Not Reported |
0 0.0%
|
1 1.4%
|
1 0.7%
|
|
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 74 participants | 74 participants | 148 participants | |
Asian |
1 1.4%
|
0 0.0%
|
1 0.7%
|
|
Black |
30 40.5%
|
31 41.9%
|
61 41.2%
|
|
White |
41 55.4%
|
37 50.0%
|
78 52.7%
|
|
Native Hawaiian or Pacific Islander |
0 0.0%
|
2 2.7%
|
2 1.4%
|
|
Other |
2 2.7%
|
3 4.1%
|
5 3.4%
|
|
American Indian or Alaska Native |
0 0.0%
|
1 1.4%
|
1 0.7%
|
|
HCV RNA Category
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 74 participants | 74 participants | 148 participants | |
< 800,000 IU/mL |
25 33.8%
|
14 18.9%
|
39 26.4%
|
|
≥ 800,000 IU/mL |
49 66.2%
|
60 81.1%
|
109 73.6%
|
|
HIV-1 RNA Category
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 74 participants | 74 participants | 148 participants | |
< 50 copies/mL |
73 98.6%
|
74 100.0%
|
147 99.3%
|
|
≥ 50 copies/mL |
1 1.4%
|
0 0.0%
|
1 0.7%
|
|
HCV RNA
Mean (Standard Deviation) Unit of measure: Log10 IU/mL |
||||
Number Analyzed | 74 participants | 74 participants | 148 participants | |
6.0 (1.07) | 6.3 (0.74) | 6.2 (0.92) |
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
Name/Title: | Gilead Clinical Study Information Center |
Organization: | Gilead Sciences |
Phone: | 1-833-445-3230 (GILEAD-0) |
EMail: | GileadClinicalTrials@gilead.com |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT02707601 |
Other Study ID Numbers: |
GS-US-366-1992 2014-004545-27 ( EudraCT Number ) |
First Submitted: | March 9, 2016 |
First Posted: | March 14, 2016 |
Results First Submitted: | September 12, 2018 |
Results First Posted: | October 9, 2018 |
Last Update Posted: | November 14, 2018 |