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Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds

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ClinicalTrials.gov Identifier: NCT01285050
Recruitment Status : Completed
First Posted : January 27, 2011
Results First Posted : November 29, 2016
Last Update Posted : November 29, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
David Thomas, Johns Hopkins University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions HIV Infection
Hepatitis C
Interventions Drug: Antiretroviral therapy (ART)
Drug: raltegravir
Drug: Emtricitabine and tenofovir disoproxil fumarate
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pre Post ART
Hide Arm/Group Description

HCV and HIV viral load pre and post antiretroviral therapy

Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.

raltegravir: HIV medication, 400 mg twice daily by mouth

Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth

Period Title: Overall Study
Started 20
Completed 19
Not Completed 1
Arm/Group Title Pre Post ART
Hide Arm/Group Description

HCV and HIV viral load pre and post antiretroviral therapy

Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.

raltegravir: HIV medication, 400 mg twice daily by mouth

Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
  95.0%
>=65 years
1
   5.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
4
  20.0%
Male
16
  80.0%
HCV infected  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
20
1.Primary Outcome
Title HCV RNA
Hide Description HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.
Time Frame 48 hours after interferon administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre ART HCV RNA Decline Post ART HCV Decline
Hide Arm/Group Description:

HCV viral load determined by RT-PCR and reported as log IU/ml before giving antiretroviral therapy (ART)

Interferon alfa-2b was administered once as part of a pharmacokinetic study before and after ART.

ART included:

raltegravir: HIV medication, 400 mg twice daily by mouth

Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth

HCV RNA determined by RT-PCR and expressed as log IU/ml after ART
Overall Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: log IU/ml
0.65
(0.17 to 1.15)
0.81
(0.34 to 1.47)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pre Post ART
Hide Arm/Group Description

HCV and HIV viral load pre and post antiretroviral therapy

Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.

raltegravir: HIV medication, 400 mg twice daily by mouth

Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth

All-Cause Mortality
Pre Post ART
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pre Post ART
Affected / at Risk (%) # Events
Total   1/20 (5.00%)    
Injury, poisoning and procedural complications   
bleeding  [1]  1/20 (5.00%)  1
Indicates events were collected by systematic assessment
[1]
As an expected potential complication of liver biopsy, one patient had bleeding that required observation in the hospital. No residual complications were noted.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pre Post ART
Affected / at Risk (%) # Events
Total   0/20 (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
Name/Title: David Thomas
Organization: Johns Hopkins University
Phone: 410-502-6043
Responsible Party: David Thomas, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01285050     History of Changes
Other Study ID Numbers: NA00040361
R01DA013806 ( U.S. NIH Grant/Contract )
First Submitted: January 26, 2011
First Posted: January 27, 2011
Results First Submitted: August 15, 2016
Results First Posted: November 29, 2016
Last Update Posted: November 29, 2016