Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 55 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection (SWIFT-C)

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: NCT02128217
Recruitment Status : Completed
First Posted : May 1, 2014
Results First Posted : March 30, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV-1 Infection
Hepatitis
Interventions Drug: Sofosbuvir
Drug: Ribavirin
Drug: Ledipasvir/Sofosbuvir
Enrollment 44
Recruitment Details Participants were enrolled at 12 different study sites in the United States. For Cohort 1, the first participant enrolled on 30 May 2014; the last participant enrolled on 7 October 2014. For Cohort 2, the first participant enrolled on 31 August 2015; the last participant enrolled on 27 September 2015.
Pre-assignment Details  
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Period Title: Overall Study
Started 17 27
Completed 17 26
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks Total
Hide Arm/Group Description

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin(RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Total of all reporting groups
Overall Number of Baseline Participants 17 27 44
Hide Baseline Analysis Population Description
Participants who enrolled and started first dose of study treatment.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 17 participants 27 participants 44 participants
45
(41 to 47)
46
(38 to 50)
45.5
(38.5 to 49.5)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 17 participants 27 participants 44 participants
20-29 years
3
  17.6%
1
   3.7%
4
   9.1%
30-39 years
1
   5.9%
8
  29.6%
9
  20.5%
40-49 years
10
  58.8%
10
  37.0%
20
  45.5%
50-59 years
2
  11.8%
6
  22.2%
8
  18.2%
60-69 years
1
   5.9%
1
   3.7%
2
   4.5%
70+ years
0
   0.0%
1
   3.7%
1
   2.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 27 participants 44 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
17
 100.0%
27
 100.0%
44
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 17 participants 27 participants 44 participants
White Non-Hispanic
6
  35.3%
11
  40.7%
17
  38.6%
Black Non-Hispanic
0
   0.0%
5
  18.5%
5
  11.4%
Hispanic (Regardless of Race)
11
  64.7%
9
  33.3%
20
  45.5%
Asian, Pacific Islander
0
   0.0%
2
   7.4%
2
   4.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 17 participants 27 participants 44 participants
17
 100.0%
27
 100.0%
44
 100.0%
Intravenous Drug History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 27 participants 44 participants
Never
13
  76.5%
22
  81.5%
35
  79.5%
Currently
0
   0.0%
1
   3.7%
1
   2.3%
Previously
4
  23.5%
4
  14.8%
8
  18.2%
Weight  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 27 participants 44 participants
Less than 75 kg
7
  41.2%
12
  44.4%
19
  43.2%
Greater than or equal to 75 kg
10
  58.8%
15
  55.6%
25
  56.8%
Type of Acute HCV Infection  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 27 participants 44 participants
New Infection
17
 100.0%
22
  81.5%
39
  88.6%
Reinfection
0
   0.0%
5
  18.5%
5
  11.4%
HCV Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 27 participants 44 participants
1a
11
  64.7%
23
  85.2%
34
  77.3%
1b
2
  11.8%
3
  11.1%
5
  11.4%
1 (subtype unknown)
2
  11.8%
0
   0.0%
2
   4.5%
2b
1
   5.9%
0
   0.0%
1
   2.3%
4
0
   0.0%
1
   3.7%
1
   2.3%
Indeterminate
1
   5.9%
0
   0.0%
1
   2.3%
IL28B Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 27 participants 44 participants
CC
4
  23.5%
16
  59.3%
20
  45.5%
CT
10
  58.8%
7
  25.9%
17
  38.6%
TT
3
  17.6%
4
  14.8%
7
  15.9%
HCV RNA  
Median (Inter-Quartile Range)
Unit of measure:  IU/mL
Number Analyzed 17 participants 27 participants 44 participants
2280000
(272000 to 4230000)
1490000
(32500 to 3560000)
1500000
(117500 to 3895000)
HCV RNA Levels  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 27 participants 44 participants
< 6 million IU/mL
15
  88.2%
21
  77.8%
36
  81.8%
>= 6 million IU/mL
2
  11.8%
6
  22.2%
8
  18.2%
HIV RNA   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 27 participants 43 participants
<50 copies/mL
15
  93.8%
27
 100.0%
42
  97.7%
>= 50 copies/mL
1
   6.3%
0
   0.0%
1
   2.3%
[1]
Measure Analysis Population Description: One participant in Cohort 1 did not have HIV RNA results obtained at baseline.
Received HIV ARVs Prior to Study Entry  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 27 participants 44 participants
Yes
16
  94.1%
27
 100.0%
43
  97.7%
No
1
   5.9%
0
   0.0%
1
   2.3%
History of Sexually Transmitted Infections  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 27 participants 44 participants
Reported History of STI Diagnosis
8
  47.1%
11
  40.7%
19
  43.2%
No History of STI Diagnosis
9
  52.9%
16
  59.3%
25
  56.8%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 (SVR12)
Hide Description

SVR12 was defined as HCV RNA undetectable less than the lower limit of quantification, Target Not Detected (<LLOQ TND) of the assay at 12 weeks after date of last dose of study treatment.

For both Cohort 1 and Cohort 2, the 12 week measurement used for determining SVR12 was the measurement obtained closest to 84 days (i.e. 12*7 days), within the window 79 to 112 days inclusive. If a participant did not have an HCV RNA measurement within this window, then the participant was considered as having detectable HCV RNA at 12 weeks unless the preceding and subsequent HCV RNA measurements were both undetectable (<LLOQ TND).

A two-sided 90% confidence interval was calculated for this percentage using the Blyth-Still-Casella method.

Time Frame At 12 weeks after date of last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who enrolled and started at least one dose of study treatment
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 17 27
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
58.8
(36.4 to 77.5)
100.0
(89.9 to 100.0)
2.Primary Outcome
Title Percentage of Participants With an Occurrence of a Grade ≥ 2 Adverse Event, Serious AE According to ICH Criteria, or Treatment-limiting AE.
Hide Description

Any adverse event occurring after initiation of study treatment through to 28 days after the date of last dose of study treatment was included (except that an event that was ongoing at the same grade from before start of study treatment was excluded). Adverse events consisted of Grade ≥ 2 primary diagnosis, primary sign/symptoms, and primary laboratory abnormality. It also included any serious adverse event according to ICH criteria and any treatment-limiting AE (ie, an AE reported as the reason for permanent discontinuation of study treatment).

A two-sided 90% confidence interval was calculated for the percentage using the Blyth-Still-Casella method.

Time Frame From initiation of study treatment to 28 days after last dose of study treatment. The duration for study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who enrolled and started first dose of study treatment.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 17 27
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
47.1
(27.7 to 68.9)
33.3
(20.4 to 50.0)
3.Secondary Outcome
Title Percentage of Participants With HCV RNA Undetectable During Study Treatment
Hide Description

HCV RNA undetectable was defined as an HCV RNA measurement <LLOQ, TND. If there was no measurement at a scheduled time, then the participant was considered as having detectable HCV RNA at that time, unless both the preceding and succeeding measurements were undetectable.

A two-sided 90% confidence interval was calculated for each proportion using the Blyth-Still-Casella method.

Time Frame 1, 2, 4, 8 and, for the 12-week regimen, 12 weeks after starting study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who successfully enrolled and started first dose of treatment.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 17 27
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
On-treatment Week 1
11.8
(3.2 to 31.1)
18.5
(9.3 to 34.7)
On Treatment Week 2
29.4
(14.0 to 50.0)
44.4
(29.1 to 61.8)
On-treatment Week 4
70.6
(50.0 to 86.6)
81.5
(65.3 to 90.7)
On-treatment Week 8
100.0
(86.0 to 100.0)
92.6
(79.6 to 98.0)
On-treatment Week 12
100.0
(86.0 to 100.0)
NA [1] 
(NA to NA)
[1]
On treatment week 12 visits did not apply to Cohort 2 because Cohort 2 was assigned only 8 weeks of treatment.
4.Secondary Outcome
Title Percentage of Participants With HCV RNA Undetectable After End of Study Treatment
Hide Description

HCV RNA undetectable is defined as an HCV RNA measurement <LLOQ, TND. If there was no measurement at a scheduled time, then the participant was considered as having detectable HCV RNA at that time, unless both the preceding and succeeding measurements were undetectable. This outcome measure was referred to as SVR2, SVR4, SVR8 and SVR24 where SVR means sustained virologic response.

A two-sided 90% confidence interval was calculated for the percentage using the Blyth-Still-Casella method.

Time Frame 2, 4, 8 and 24 weeks after last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description

Participants who successfully enrolled and started first dose of treatment.

Note that one participant in Cohort 2 was lost to follow-up prior to week 24 and is imputed as not having SVR24 at week 24. This participant, however, had HCV RNA < LLOQ, TND at all moments from week 4 of study treatment.

Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred 24 through to weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 17 27
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
SVR2 Number Analyzed 17 participants 27 participants
64.7
(43.2 to 82.5)
100.0
(89.9 to 100.0)
SVR4 Number Analyzed 17 participants 27 participants
58.8
(36.4 to 77.5)
96.3
(84.3 to 99.6)
SVR8 Number Analyzed 17 participants 27 participants
58.8
(36.4 to 77.5)
96.3
(84.3 to 99.6)
SVR24 Number Analyzed 17 participants 26 participants
64.7
(43.2 to 82.5)
96.3
(84.3 to 99.6)
5.Secondary Outcome
Title Number of Participants Who Had HCV Virologic Relapse
Hide Description HCV virologic relapse was defined as HCV RNA undetectable at end-of-treatment but HCV RNA quantifiable during follow-up with subsequent confirmation as quantifiable.
Time Frame From end of study treatment through to 24 weeks after end of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who successfully enrolled and started first dose of treatment.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 17 27
Measure Type: Count of Participants
Unit of Measure: Participants
7
  41.2%
0
   0.0%
6.Secondary Outcome
Title Percentage of HCV Virologic Failure Participants That Developed SOF- or LDV-Associated Resistance Mutations
Hide Description Percentage of participants who developed SOF- or LDV-associated resistance mutation found within HCV Virologic Failure participants. HCV virologic failure was defined as HCV RNA undetectable at end-of-treatment but HCV RNA quantifiable during follow-up with subsequent confirmation as quantifiable.
Time Frame At time of HCV virologic failure; any time from start of study treatment to 24 weeks after end of study treatment. Duration of study treatment for Cohort 1 and 2 were 12 and 8 weeks, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who observed an HCV virologic failure after successfully enrolling for first dose of treatment.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up through to occurred 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 7 0
Measure Type: Number
Unit of Measure: Percentage of participants
0.00
7.Secondary Outcome
Title Count and Percentage of Participants With an Adverse Event by Type.
Hide Description The adverse events considered were Grade 2 or higher adverse events (primary diagnosis, primary sign and symptom, or a primary lab), SAE according to ICH criteria, or treatment-limiting adverse events. Participants may experience more than one type of adverse event.
Time Frame Any time from start of treatment to 28 days after date of last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who successfully enrolled and received first dose of treatment.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 17 27
Measure Type: Count of Participants
Unit of Measure: Participants
Primary Diagnosis
0
   0.0%
2
   7.4%
Primary Sign/Symptom
5
  29.4%
4
  14.8%
Primary Lab
5
  29.4%
6
  22.2%
Serious Adverse Event
0
   0.0%
1
   3.7%
Treatment-Limiting Adverse Event
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Count of Participants With HIV-1 RNA <50 Copies/mL
Hide Description Because all except one participant had HIV-1 RNA < 50 copies/mL, participants were categorized according to whether or not their HIV-1 RNA was <5 copies/mL at each follow-up evaluation.
Time Frame 4 and 12 weeks after start of study treatment for Cohort 1. 4 and 8 weeks after start of study treatment for the 8-week regimen used in Cohort 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who enrolled successfully, received HIV ARV regimen at entry and started first dose of treatment
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 17 27
Measure Type: Count of Participants
Unit of Measure: Participants
On-treatment Week 4 Number Analyzed 17 participants 27 participants
≥50 copies/mL
0
   0.0%
0
   0.0%
<50 copies/mL
17
 100.0%
27
 100.0%
On-treatment Week 8 Number Analyzed 0 participants 23 participants
≥50 copies/mL 0
0
   0.0%
<50 copies/mL 0
23
 100.0%
On-treatment Week 12 Number Analyzed 17 participants 0 participants
≥50 copies/mL
0
   0.0%
0
<50 copies/mL
17
 100.0%
0
9.Secondary Outcome
Title Change in CD4+ Cell Count
Hide Description The change in CD4+ cell count from baseline to 12 weeks after the end of study treatment.
Time Frame Baseline to 12 weeks after end of study treatment. Duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who successfully enrolled and recieved first dose of treatment.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 16 24
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
11  (111) 61  (125)
10.Secondary Outcome
Title Self-reported Adherence to SOF
Hide Description Count and percentage of participants who reported having taken all doses of SOF. This outcome measure was evaluated in Cohort 1 only.
Time Frame 1, 2, 4, 8 and 12 weeks after starting study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 1 who successfully enrolled and received first dose of SOF+weight-based RBV.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 17 0
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1 Number Analyzed 17 participants 0 participants
17
 100.0%
Week 2 Number Analyzed 16 participants 0 participants
16
 100.0%
Week 4 Number Analyzed 16 participants 0 participants
16
 100.0%
Week 8 Number Analyzed 17 participants 0 participants
16
  94.1%
Week 12 Number Analyzed 15 participants 0 participants
15
 100.0%
11.Secondary Outcome
Title Adherence as Measured by SOF Pill Count
Hide Description The count and percentage of participants who had a pill count consistent with 100% of SOF doses taken. This outcome measure was evaluated in Cohort 1 only.
Time Frame 12 weeks after starting study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 1 who successfully enrolled and received first dose of SOF+weight-based RBV.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 17 0
Measure Type: Count of Participants
Unit of Measure: Participants
Pill count not available
12
  70.6%
Pill count consistent with 100% of doses taken
4
  23.5%
Pill count indicates <100% of doses taken
1
   5.9%
12.Secondary Outcome
Title Self-reported Adherence to RBV
Hide Description Count and percentage of participants who reported having taken all doses of RBV. This outcome measure was evaluated in Cohort 1 only.
Time Frame 1, 2, 4, 8 and 12 weeks after starting study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 1 who successfully enrolled and received first dose of SOF+weight-based RBV.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 17 0
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1 Number Analyzed 16 participants 0 participants
16
 100.0%
Week 2 Number Analyzed 16 participants 0 participants
15
  93.8%
Week 4 Number Analyzed 16 participants 0 participants
15
  93.8%
Week 8 Number Analyzed 17 participants 0 participants
16
  94.1%
Week 12 Number Analyzed 15 participants 0 participants
15
 100.0%
13.Secondary Outcome
Title Adherence as Measured by RBV Pill Count
Hide Description The count and percentage of participants who had a pill count consistent with 100% of RBV doses taken. This outcome measure was evaluated in Cohort 1 only.
Time Frame 12 weeks after starting study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 1 who successfully enrolled and received first dose of SOF + weight-based RBV.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 17 0
Measure Type: Count of Participants
Unit of Measure: Participants
Pill count not available
12
  70.6%
Pill count consistent with 100% of doses taken
1
   5.9%
Pill count indicates <100% of doses taken
4
  23.5%
14.Secondary Outcome
Title Self-reported Adherence to LDV/SOF
Hide Description Count and percentage of participants who reported having taken all doses of LDV/SOF. This outcome measure was evaluated in Cohort 2 only.
Time Frame 1, 2, 4, and 8 weeks after starting study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 2 who successfully enrolled and received first dose of LDV/SOF.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 0 27
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1 Number Analyzed 0 participants 25 participants
25
 100.0%
Week 2 Number Analyzed 0 participants 25 participants
25
 100.0%
Week 4 Number Analyzed 0 participants 27 participants
27
 100.0%
Week 8 Number Analyzed 0 participants 23 participants
18
  78.3%
15.Secondary Outcome
Title Adherence as Measured by LDV/SOF Pill Count
Hide Description The count and percentage of participants who had a pill count consistent with 100% of LDV/SOF doses taken.. This outcome measure was evaluated in Cohort 2 only.
Time Frame 8 weeks after starting study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 2 who successfully enrolled and received first dose of LDV/SOF.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 0 27
Measure Type: Count of Participants
Unit of Measure: Participants
Pill count not available
7
  25.9%
Pill count consistent with 100% of doses taken
17
  63.0%
Pill count indicates <100% of doses taken
3
  11.1%
16.Secondary Outcome
Title Ribavirin Concentration in Plasma
Hide Description Ribavirin concentration in plasma. This outcome was evaluated in Cohort 1 only.
Time Frame 4, 8, and 12 weeks after starting study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 1 who successfully enrolled and received first dose of SOF + weight-based RBV.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 17 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Week 4 Number Analyzed 17 participants 0 participants
1803
(45.6%)
week 8 Number Analyzed 17 participants 0 participants
2122
(30.0%)
Week 12 Number Analyzed 16 participants 0 participants
2013
(36.4%)
17.Secondary Outcome
Title Cellular Concentration of Tenofovir Diphosphate (TFV-DP)
Hide Description Cellular concentration of tenofovir diphosphate (TFV-DP) from dried blood spot samples.
Time Frame Baseline (before HCV study treatment), EOT (end of trial dosing), 12 weeks after end of HCV study treatment. The duration of HCV study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who started first dose of study treatment and also took tenofovir disoporxil fumarate (TDF) for treatment of HIV infection.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 15 22
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: fmol/punch
Baseline Number Analyzed 13 participants 22 participants
1687
(30.7%)
1516
(36.2%)
End of treatment Number Analyzed 13 participants 20 participants
6607
(73.8%)
26846
(49.3%)
12 Weeks after end of HCV study treatment Number Analyzed 13 participants 16 participants
2100
(36.4%)
1644
(54.6%)
18.Secondary Outcome
Title Concentration of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs)
Hide Description Concentration of tenofovir diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs). This outcome is measured in Cohort 1 only.
Time Frame Baseline (before SOF + RBV dosing), EOT (end of study treatment), 12 weeks after end of HCV study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Cohort 1 who successfully enrolled and received first dose of SOF + weight-based RBV and who were also taking tenofovir disoproxil fumarate (TDF) for treatment of HIV infection.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 15 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: fmol/10^6 cells
Baseline Number Analyzed 12 participants 0 participants
79
(47.9%)
End of treatment Number Analyzed 12 participants 0 participants
149
(91.3%)
12 Weeks after end of HCV study treatment Number Analyzed 11 participants 0 participants
81
(54.4%)
19.Secondary Outcome
Title Concentration of Tenofovir (TFV) in Plasma
Hide Description Concentration of tenofovir (TFV) in plasma among participants who took TFV for treatment of HIV infection.
Time Frame Baseline (before HCV study treatment), EOT (end of trial dosing), 12 weeks after end of HCV study treatment. The duration of HCV study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who started first dose of study treatment and also took tenofovir (TFV) for treatment of HIV infection.
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description:

Follow-up occurred through to 24 weeks after the end of treatment.

Ribavirin (RBV): Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Sofosbuvir (SOF): Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Follow-up occurred through to 24 weeks after the end of treatment.

Ledipasvir/Sofosbuvir (LDV/SOF): Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.

Overall Number of Participants Analyzed 15 22
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Baseline Number Analyzed 14 participants 19 participants
98
(62.6%)
87
(97.6%)
End of treatment Number Analyzed 13 participants 20 participants
96
(57.2%)
155
(112.1%)
12 Weeks after end of HCV study treatment Number Analyzed 11 participants 16 participants
94
(75.7%)
76
(66.2%)
Time Frame From study entry to 24 weeks after completing study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.
Adverse Event Reporting Description The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of >=Grade 2, SAEs, and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V2.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
 
Arm/Group Title Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Hide Arm/Group Description

Follow-up occurred 24 weeks after the end of treatment. Ribavirin: Participants received weight-based RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.

Sofosbuvir: Participants received one 400 mg tablet of sofosbuvir orally every morning with food.

Follow-up occurred 24 weeks after the end of treatment. Ledipasvir/Sofosbuvir: Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of LDV and 400 mg of SOF.
All-Cause Mortality
Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/27 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   2/27 (7.41%) 
Cardiac disorders     
Coronary artery disease  1  0/17 (0.00%)  1/27 (3.70%) 
Injury, poisoning and procedural complications     
Subdural haematoma  1  0/17 (0.00%)  1/27 (3.70%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: SOF+Weight-based RBV for 12 Wks Cohort 2: LDV/SOF for 8 Wks
Affected / at Risk (%) Affected / at Risk (%)
Total   17/17 (100.00%)   24/27 (88.89%) 
General disorders     
Fatigue  1  2/17 (11.76%)  1/27 (3.70%) 
Pyrexia  1  1/17 (5.88%)  0/27 (0.00%) 
Infections and infestations     
Genitourinary tract gonococcal infection  1  1/17 (5.88%)  0/27 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  14/17 (82.35%)  20/27 (74.07%) 
Aspartate aminotransferase increased  1  14/17 (82.35%)  18/27 (66.67%) 
Blood alkaline phosphatase abnormal  1  0/17 (0.00%)  2/27 (7.41%) 
Blood alkaline phosphatase increased  1  1/17 (5.88%)  2/27 (7.41%) 
Blood bilirubin increased  1  3/17 (17.65%)  5/27 (18.52%) 
Blood cholesterol increased  1  2/17 (11.76%)  0/27 (0.00%) 
Blood creatinine increased  1  1/17 (5.88%)  4/27 (14.81%) 
Blood glucose decreased  1  0/17 (0.00%)  4/27 (14.81%) 
Blood glucose increased  1  2/17 (11.76%)  3/27 (11.11%) 
Blood phosphorus decreased  1  1/17 (5.88%)  0/27 (0.00%) 
Blood potassium decreased  1  0/17 (0.00%)  2/27 (7.41%) 
Blood sodium decreased  1  1/17 (5.88%)  1/27 (3.70%) 
Lipase abnormal  1  3/17 (17.65%)  0/27 (0.00%) 
Lipase increased  1  0/17 (0.00%)  2/27 (7.41%) 
Low density lipoprotein increased  1  1/17 (5.88%)  0/27 (0.00%) 
Neutrophil count decreased  1  0/17 (0.00%)  2/27 (7.41%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  1/17 (5.88%)  0/27 (0.00%) 
Nervous system disorders     
Headache  1  0/17 (0.00%)  2/27 (7.41%) 
Psychiatric disorders     
Initial insomnia  1  1/17 (5.88%)  0/27 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/17 (0.00%)  2/27 (7.41%) 
Nasal congestion  1  1/17 (5.88%)  1/27 (3.70%) 
Skin and subcutaneous tissue disorders     
Blister  1  1/17 (5.88%)  0/27 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
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.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
EMail: ACTGCT.Gov@s-3.com
Layout table for additonal information
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT02128217     History of Changes
Other Study ID Numbers: ACTG A5327
UM1AI068636 ( U.S. NIH Grant/Contract )
First Submitted: April 29, 2014
First Posted: May 1, 2014
Results First Submitted: February 28, 2018
Results First Posted: March 30, 2018
Last Update Posted: April 27, 2018