Trial Outcomes & Findings for Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds (NCT NCT01285050)
NCT ID: NCT01285050
Last Updated: 2016-11-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
48 hours after interferon administration
Results posted on
2016-11-29
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds
Baseline characteristics by cohort
| Measure |
Pre Post ART
n=20 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
|
HCV infected
|
20 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 48 hours after interferon administrationHCV 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.
Outcome measures
| Measure |
Pre ART HCV RNA Decline
n=19 Participants
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
|
Post ART HCV Decline
n=19 Participants
HCV RNA determined by RT-PCR and expressed as log IU/ml after ART
|
|---|---|---|
|
HCV RNA
|
0.65 log IU/ml
Interval 0.17 to 1.15
|
0.81 log IU/ml
Interval 0.34 to 1.47
|
Adverse Events
Pre Post ART
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre Post ART
n=20 participants at risk
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
|
|---|---|
|
Injury, poisoning and procedural complications
bleeding
|
5.0%
1/20 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place