Trial Outcomes & Findings for Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection (NCT NCT01147107)
NCT ID: NCT01147107
Last Updated: 2021-08-13
Results Overview
To estimate the rates of grade 2\*and higher ALT elevations in the two regimens.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
over week 72
Results posted on
2021-08-13
Participant Flow
Participant milestones
| Measure |
Raltegravir Based Therapy
Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
Raltegravir: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
|
Efavirenz Based Therapy
Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
Efavirenz: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
41
|
|
Overall Study
COMPLETED
|
33
|
40
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
Raltegravir Based Therapy
Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
Raltegravir: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
|
Efavirenz Based Therapy
Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
Efavirenz: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection
Baseline characteristics by cohort
| Measure |
Raltegravir Based Therapy
n=38 Participants
Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
Raltegravir: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
|
Efavirenz Based Therapy
n=41 Participants
Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
Efavirenz: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
33 years
n=7 Participants
|
32 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Vietnam
|
38 participants
n=5 Participants
|
41 participants
n=7 Participants
|
79 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: over week 72To estimate the rates of grade 2\*and higher ALT elevations in the two regimens.
Outcome measures
| Measure |
Raltegravir Based Therapy
n=38 Participants
Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
Raltegravir: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
|
Efavirenz Based Therapy
n=41 Participants
Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
Efavirenz: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
|
|---|---|---|
|
Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations
|
24 Participants
|
30 Participants
|
Adverse Events
Raltegravir Based Therapy
Serious events: 8 serious events
Other events: 21 other events
Deaths: 2 deaths
Efavirenz Based Therapy
Serious events: 8 serious events
Other events: 29 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Raltegravir Based Therapy
n=38 participants at risk
Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
Raltegravir: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
|
Efavirenz Based Therapy
n=41 participants at risk
Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
Efavirenz: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
|
|---|---|---|
|
Injury, poisoning and procedural complications
Car Accident
|
2.6%
1/38 • Number of events 1 • 72 weeks
|
0.00%
0/41 • 72 weeks
|
|
General disorders
Suicide
|
0.00%
0/38 • 72 weeks
|
2.4%
1/41 • Number of events 1 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tuberculosis
|
2.6%
1/38 • Number of events 1 • 72 weeks
|
7.3%
3/41 • Number of events 3 • 72 weeks
|
|
Gastrointestinal disorders
Infectious Diarrhea
|
0.00%
0/38 • 72 weeks
|
2.4%
1/41 • Number of events 1 • 72 weeks
|
|
Nervous system disorders
CNS Syndrome Unclear Etiology
|
0.00%
0/38 • 72 weeks
|
2.4%
1/41 • Number of events 1 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PCP Pneumonia
|
2.6%
1/38 • Number of events 1 • 72 weeks
|
0.00%
0/41 • 72 weeks
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
2.6%
1/38 • Number of events 1 • 72 weeks
|
0.00%
0/41 • 72 weeks
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/38 • 72 weeks
|
2.4%
1/41 • Number of events 1 • 72 weeks
|
|
Renal and urinary disorders
Pyelonephritis
|
2.6%
1/38 • Number of events 1 • 72 weeks
|
0.00%
0/41 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bacterial Pneumonia
|
2.6%
1/38 • Number of events 1 • 72 weeks
|
0.00%
0/41 • 72 weeks
|
|
Nervous system disorders
PML
|
0.00%
0/38 • 72 weeks
|
2.4%
1/41 • Number of events 1 • 72 weeks
|
|
Hepatobiliary disorders
Hepatic Encephalopathy
|
2.6%
1/38 • Number of events 1 • 72 weeks
|
0.00%
0/41 • 72 weeks
|
|
Infections and infestations
Septic Shock
|
2.6%
1/38 • Number of events 1 • 72 weeks
|
0.00%
0/41 • 72 weeks
|
Other adverse events
| Measure |
Raltegravir Based Therapy
n=38 participants at risk
Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
Raltegravir: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
|
Efavirenz Based Therapy
n=41 participants at risk
Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
Efavirenz: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
|
|---|---|---|
|
Hepatobiliary disorders
ALT Elevation
|
55.3%
21/38 • 72 weeks
|
70.7%
29/41 • 72 weeks
|
Additional Information
Dr. Cecilia Shikuma
University of Hawaii at Manoa John A Burns School of Medicine
Phone: 8086921328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place