Trial Outcomes & Findings for Peginterferon Alpha-2a and Ribavirin to Treat Hepatitis C in HIV-infected Patients (NCT NCT00085917)
NCT ID: NCT00085917
Last Updated: 2011-06-27
Results Overview
SVR \[ Sustained virological response\] SVR was defined as HCV RNA levels below the limit of detection 24 weeks after the end of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
72 weeks
Results posted on
2011-06-27
Participant Flow
Recruitment period was over a period of 3 yrs from 2004 - 2007. Participants were recruited and screened through the OP8 clinic of the NIAID.
There were no significant events or approaches following participant enrollment prior to group assignments. However if enrolled participants subsequently developed exclusion criteria such as active alcohol or drug abuse, they were excluded from the study.
Participant milestones
| Measure |
Pegasys Single Dose
pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg)
\- Treatment for 48 weeks
|
Pegasys Double Dose
pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 44 weeks
\- Total Treatment for 48 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Pegasys Single Dose
pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg)
\- Treatment for 48 weeks
|
Pegasys Double Dose
pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 44 weeks
\- Total Treatment for 48 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
Baseline Characteristics
Peginterferon Alpha-2a and Ribavirin to Treat Hepatitis C in HIV-infected Patients
Baseline characteristics by cohort
| Measure |
Pegasys Single Dose
n=15 Participants
pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg)
\- Treatment for 48 weeks
|
Pegasys Double Dose
n=14 Participants
pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 44 weeks
\- Total Treatment for 48 weeks
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
48 years
STANDARD_DEVIATION 6.402 • n=5 Participants
|
46 years
STANDARD_DEVIATION 5.93 • n=7 Participants
|
47 years
STANDARD_DEVIATION 6.109 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 72 weeksSVR \[ Sustained virological response\] SVR was defined as HCV RNA levels below the limit of detection 24 weeks after the end of treatment.
Outcome measures
| Measure |
Pegasys Single Dose
n=11 Participants
pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg)
\- Treatment for 48 weeks
|
Pegasys Double Dose
n=11 Participants
pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 44 weeks
\- Total Treatment for 48 weeks
|
|---|---|---|
|
Number of Participants With Sustained Virologic Response (SVR)
|
11 participants
|
11 participants
|
SECONDARY outcome
Timeframe: week 24, week 48, week 72normalization of liver enzymes :Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) Alanine aminotransferase (ALT): Normal 6 - 41 U/L Aspartate aminotransferase (AST) : Normal 9 - 34 U/L
Outcome measures
| Measure |
Pegasys Single Dose
n=11 Participants
pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg)
\- Treatment for 48 weeks
|
Pegasys Double Dose
n=11 Participants
pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 44 weeks
\- Total Treatment for 48 weeks
|
|---|---|---|
|
Number of Participants With Normalization of Liver Enzymes
|
11 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 48 weeksAdverse Events \- Anemia, Neutropenia and Psychiatric adverse events
Outcome measures
| Measure |
Pegasys Single Dose
n=11 Participants
pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg)
\- Treatment for 48 weeks
|
Pegasys Double Dose
n=11 Participants
pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 44 weeks
\- Total Treatment for 48 weeks
|
|---|---|---|
|
Number of Participants With Adverse Events
|
11 participants
|
11 participants
|
Adverse Events
Pegasys Single Dose
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Pegasys Double Dose
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pegasys Single Dose
n=11 participants at risk
pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg)
\- Treatment for 48 weeks
|
Pegasys Double Dose
n=11 participants at risk
pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 44 weeks
\- Total Treatment for 48 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
18.2%
2/11 • Number of events 2 • 2 YEARS
|
54.5%
6/11 • Number of events 6 • 2 YEARS
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • 2 YEARS
|
9.1%
1/11 • Number of events 1 • 2 YEARS
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • Number of events 1 • 2 YEARS
|
9.1%
1/11 • Number of events 1 • 2 YEARS
|
Other adverse events
| Measure |
Pegasys Single Dose
n=11 participants at risk
pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg)
\- Treatment for 48 weeks
|
Pegasys Double Dose
n=11 participants at risk
pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight\<75kg, 1200mg daily for weight \>75kg) for 44 weeks
\- Total Treatment for 48 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
54.5%
6/11 • Number of events 6 • 2 YEARS
|
63.6%
7/11 • Number of events 7 • 2 YEARS
|
|
Psychiatric disorders
Depression/anxiety
|
54.5%
6/11 • Number of events 6 • 2 YEARS
|
54.5%
6/11 • Number of events 6 • 2 YEARS
|
|
Blood and lymphatic system disorders
Neutropenia
|
81.8%
9/11 • Number of events 9 • 2 YEARS
|
72.7%
8/11 • Number of events 9 • 2 YEARS
|
|
General disorders
Fatigue
|
18.2%
2/11 • Number of events 2 • 2 YEARS
|
27.3%
3/11 • Number of events 3 • 2 YEARS
|
|
General disorders
Weight loss
|
18.2%
2/11 • Number of events 2 • 2 YEARS
|
27.3%
3/11 • Number of events 3 • 2 YEARS
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
36.4%
4/11 • Number of events 4 • 2 YEARS
|
36.4%
4/11 • Number of events 4 • 2 YEARS
|
|
Hepatobiliary disorders
Elevated transaminases
|
72.7%
8/11 • Number of events 8 • 2 YEARS
|
54.5%
6/11 • Number of events 6 • 2 YEARS
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place