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Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs

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ClinicalTrials.gov Identifier: NCT02347345
Recruitment Status : Completed
First Posted : January 27, 2015
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Martin Markowitz, Rockefeller University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Intervention Drug: Harvoni (Fixed dose combination ledipasvir/sofosbuvir)
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Injection Drug Use (IDU) Former Injection Drug Use (Former IDU) Healthy Volunteers
Hide Arm/Group Description In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks. In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks. HIV, HCV, and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at screening.
Period Title: Overall Study
Started 10 12 12
Completed 10 12 12
Not Completed 0 0 0
Arm/Group Title Active Injection Drug Use (IDU) Former Injection Drug Use (Former IDU) Healthy Volunteers Total
Hide Arm/Group Description In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks. In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks. HIV, HCV, and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at screening. Total of all reporting groups
Overall Number of Baseline Participants 10 12 12 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 12 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
12
 100.0%
12
 100.0%
34
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 12 participants 12 participants 34 participants
Female
3
  30.0%
4
  33.3%
4
  33.3%
11
  32.4%
Male
7
  70.0%
8
  66.7%
8
  66.7%
23
  67.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 12 participants 12 participants 34 participants
10
 100.0%
12
 100.0%
12
 100.0%
34
 100.0%
1.Primary Outcome
Title sCD14 (ng/mL)
Hide Description Marker of immune activation as measured by levels of soluble CD14. Note that the levels of sCD14 were only measured at baseline in the Healthy Volunteers group and therefore there are no data for weeks 4, 12, or 24 entered.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
9/10 Active injectors, 11/12 former injectors and 12/12 healthy volunteers completed the study.
Arm/Group Title Active Injection Drug Use (IDU) Former Injection Drug Use (Former IDU) Healthy Volunteers
Hide Arm/Group Description:

In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill orally daily x 12 weeks

Harvoni (Fixed dose combination ledipasvir/sofosbuvir): Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill daily x 12 weeks

In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill orally daily x 12 weeks

Harvoni (Fixed dose combination ledipasvir/sofosbuvir): Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill daily x 12 weeks

HIV, HCV and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at the screening visit.
Overall Number of Participants Analyzed 10 12 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
baseline Number Analyzed 10 participants 12 participants 12 participants
1986  (217) 1918  (208) 1542  (249)
week 4 Number Analyzed 10 participants 12 participants 0 participants
2060  (443) 1805  (183)
week 12 Number Analyzed 10 participants 12 participants 0 participants
2036  (339) 1782  (193)
week 24 Number Analyzed 9 participants 11 participants 0 participants
1973  (266) 1819  (193)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active Injection Drug Use (IDU), Former Injection Drug Use (Former IDU), Healthy Volunteers
Comments [Not Specified]
Type of Statistical Test Other
Comments Descriptive pilot study. Not relevant.
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Secondary Outcome
Title Virologic Response to Therapy as Measured by HCV RNA
Hide Description HCV RNA levels in plasma (IU/mL)
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
9/10 Active injectors, 11/12 former injectors and 12/12 healthy volunteers completed the study. Healthy volunteers are HCV uninfected therefore HCV RNA levels are not measured on this group of participants.
Arm/Group Title Active Injection Drug Use (IDU) Former Injection Drug Use (Former IDU) Healthy Volunteers
Hide Arm/Group Description:
In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
HIV, HCV, and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at screening.
Overall Number of Participants Analyzed 10 12 0
Mean (Standard Deviation)
Unit of Measure: HCV RNA copies/mL plasma
baseline Number Analyzed 10 participants 12 participants 0 participants
7781148  (8662099) 2320026  (3994266)
week 12 Number Analyzed 10 participants 12 participants 0 participants
0  (0) 0  (0)
week 24 Number Analyzed 9 participants 11 participants 0 participants
0  (0) 0  (0)
3.Secondary Outcome
Title Gene Expression Profiles
Hide Description Gene expression profiles in PBMC will be determined using RNA Seq
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
9/10 Active injectors, 11/12 former injectors and 12/12 healthy volunteers completed the study. Healthy volunteers were only studied at baseline. No data for weeks 4, 12, 24.
Arm/Group Title Active Injection Drug Use (IDU) Former Injection Drug Use (Former IDU) Healthy Volunteers
Hide Arm/Group Description:
In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks.
HIV, HCV, and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at screening.
Overall Number of Participants Analyzed 9 11 12
Measure Type: Number
Unit of Measure: RNA seq different from active IDU
baseline Number Analyzed 9 participants 11 participants 12 participants
9 11 12
4 weeks Number Analyzed 9 participants 11 participants 0 participants
9 11
12 weeks Number Analyzed 9 participants 11 participants 0 participants
9 11
24 weeks Number Analyzed 9 participants 11 participants 0 participants
9 11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Injection Drug Use (IDU) Former Injection Drug Use (Former IDU) Healthy Volunteers
Hide Arm/Group Description In active IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks. In former IDU, Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill oral daily x 12 weeks. HIV, HCV, and HBV negative, never injected drugs, no recreational drugs for at least 2 years (does not include marijuana) and negative urine screen for opiates at screening.
All-Cause Mortality
Active Injection Drug Use (IDU) Former Injection Drug Use (Former IDU) Healthy Volunteers
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      1/12 (8.33%)      0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active Injection Drug Use (IDU) Former Injection Drug Use (Former IDU) Healthy Volunteers
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/12 (8.33%)      0/12 (0.00%)    
General disorders       
Drug overdose * [1]  0/10 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Study subject found dead. Autopsy consistent with multiple drug overdose. Likely cause of death cardiopulmonary arrest
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Injection Drug Use (IDU) Former Injection Drug Use (Former IDU) Healthy Volunteers
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Martin Markowitz MD
Organization: Aaron Diamond AIDS Research Center
Phone: 212-448-5020
EMail: mmarkowitz@adarc.org
Layout table for additonal information
Responsible Party: Martin Markowitz, Rockefeller University
ClinicalTrials.gov Identifier: NCT02347345     History of Changes
Other Study ID Numbers: MMA-0874
5R01DA033777 ( U.S. NIH Grant/Contract )
First Submitted: January 15, 2015
First Posted: January 27, 2015
Results First Submitted: May 1, 2019
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019