Phase 4
N=80
Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection
Hepatitis C, Chronic · HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT01147107 ↗Enrolled (actual)
80
Serious AEs
20.3%
Results posted
Aug 2021
Primary outcome: Primary: Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations — 24; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Raltegravir (Drug); Efavirenz (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Hawaii
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations |
24; 30 | — |
Summary
The main objective is to evaluate the hepatic safety of raltegravir when compared to efavirenz, both in combination with tenofovir and emtricitabine as first-line HIV treatment in patients with HIV and hepatitis C coinfection.
Eligibility Criteria
Inclusion Criteria
- HIV infected patients, age >18 years, meet Vietnam guideline to begin ART (CD4 count < 350 cells/mm3 and/or WHO stage III or IV disease)
- Hepatitis C infection as documented by positive HCV antibodies and a detectable serum HCV RNA level
- AST and ALT ≤ 2 x ULN (≤ 80 U/L)
- Estimated creatinine clearance ≥ 60 mL/min
Exclusion Criteria
- Any prior ART
- Positive Hepatitis B surface antigen
- Clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal bleeding)
- Requirement for acute therapy for other AIDS-defining illness within 14 days prior to study entry
- Currently on rifampicin therapy
- In the first trimester of pregnancy, intent to become pregnant, or breast feeding during the study period
Data sourced from ClinicalTrials.gov (NCT01147107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.