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Trial Outcomes & Findings for Treatment of Acute Hepatitis C Virus in HIV Co-Infection (NCT NCT00845676)

NCT ID: NCT00845676

Last Updated: 2020-05-18

Results Overview

Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

24 weeks

Results posted on

2020-05-18

Participant Flow

All participants were enrolled at one U.S. clinical site

Participant milestones

Participant milestones
Measure
Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks.
Overall Study
STARTED
21
Overall Study
COMPLETED
19
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Experimental: Pegylated Interferon Alfa-2a + Ribavirin
Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks.
Overall Study
Virologic breakthrough at week 20
1
Overall Study
Adverse Event
1

Baseline Characteristics

Treatment of Acute Hepatitis C Virus in HIV Co-Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Experimental: Pegylated Interferon Alfa-2a + Ribavirin
n=21 Participants
Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
Age, Continuous
42 years
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
21 Participants
n=5 Participants
Region of Enrollment
United States
21 participants
n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment

Outcome measures

Outcome measures
Measure
Experimental: Pegylated Interferon Alfa-2a + Ribavirin
n=19 Participants
Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
Sustained Virologic Response (SVR)
62 percentage of participants

SECONDARY outcome

Timeframe: 48 weeks

Population: PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.

Number of participants with treatment-associated problems

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.

Predictors of SVR, including early HCV RNA response to treatment as they relate to SVR

Outcome measures

Outcome data not reported

Adverse Events

Experimental: Pegylated Interferon Alfa-2a + Ribavirin

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Experimental: Pegylated Interferon Alfa-2a + Ribavirin
n=21 participants at risk
Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
Blood and lymphatic system disorders
Neutropenia
38.1%
8/21 • Number of events 8 • 48 weeks
Infections and infestations
Virologic breakthrough
4.8%
1/21 • Number of events 1 • 48 weeks
Blood and lymphatic system disorders
anemia
19.0%
4/21 • Number of events 4 • 48 weeks

Additional Information

Brad Hare, MD

San Francisco General Hospital/UCSF

Phone: 415-476-4082

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place