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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285050
First Posted: January 27, 2011
Last Update Posted: November 29, 2016
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
David Thomas, Johns Hopkins University
Results First Submitted: August 15, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pre Post ART

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


Participant Flow:   Overall Study
    Pre Post ART
STARTED   20 
COMPLETED   19 
NOT COMPLETED   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pre Post ART

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


Baseline Measures
   Pre Post ART 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   19 
>=65 years   1 
Gender 
[Units: Participants]
 
Female   4 
Male   16 
HCV infected 
[Units: Participants]
 20 


  Outcome Measures

1.  Primary:   HCV RNA   [ Time Frame: 48 hours after interferon administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: dthomas@jhmi.edu



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



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