Hepatitis C, ChronicPhase 4NCT01147107
Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection
A Phase 4 study testing Raltegravir and Efavirenz in people with Hepatitis C, Chronic and HIV Infection, run by University of Hawaii at 2 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, HIV Infection
- What is being tested?
- Raltegravir and Efavirenz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesVietnam
- Study dates
- Feb 2014to 1 Jun 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Viet Tiep General Hospital
Haiphong
Hospital for Tropical Diseases
Ho Chi Minh City
About this study
Official title: Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C
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.
Read the detailed description
The trial will recruit 80 treatment-naive HIV-infected patients with chronic hepatitis C coinfection from two HIV treatment centers in Vietnam. Patients will be randomized to receive either raltegravir or efavirenz, both in combination of tenofovir and emtricitabine, as first-line HIV therapy over a period of 72 weeks. The primary endpoint is the rate of alanine aminotransferase (ALT) elevation during the 72 week study period. Secondary endpoints include rates of virological suppression, CD4 count change, numbers of AIDS events and death, rates of fasting glucose and cholesterol measures, neurocognitive function and levels of immune activation. Patients will be followed monthly for the first 3 months and every 3 months thereafter. At the end of the trial period, patients will be transferred to the National HIV treatment program for continuation of HIV therapy.
- Conditions
- Hepatitis C, Chronic, HIV Infection
- Being tested
- Raltegravir, Efavirenz
- Keywords
- HIV/HCV co-infection, Antiretroviral therapy
- Medical subject headings
- Hepatitis C, Chronic, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Also called Isentress
Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
EfavirenzDrug
Also called Sustiva
Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir based therapy | Experimental | Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily Receives: Drug: Raltegravir |
| Efavirenz based therapy | Active comparator | Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily Receives: Drug: Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations
To estimate the rates of grade 2*and higher ALT elevations in the two regimens.
Measured: over week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startFeb 2014
- Primary completion1 Jun 2016
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Viet Tiep Hospital, Oxford University Clinical Research Unit, Vietnam
- Responsible party
- Sponsor
- Investigators
- Van Vinh Chau Nguyen, MD, PhD, Principal investigator, Hospital for Tropical Diseases, Ho Chi Minh City, VietnamCecilia M Shikuma, M.D., Principal investigator, University of Hawaii - Hawaii Center for AIDS (HICFA)Thuy Le, M.D., Study director, University of Hawaii, Oxford University Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147107
- Sponsor's protocol ID
- VHARP 001
- Status last verified
- Jul 2021
- First submitted
- 16 Jun 2010
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: IPD will be shared with other researchers upon request following the publication of the data. Researchers will contact the PI.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C
- ClinicalTrials.gov ID
- NCT01147107
- Acronym / sponsor ID
- VHARP 001
- Conditions
- Hepatitis C, Chronic, HIV Infection
- Keywords
- HIV/HCV co-infection, Antiretroviral therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Viet Tiep Hospital, Oxford University Clinical Research Unit, Vietnam
- Study start
- Feb 2014 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 13 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial will recruit 80 treatment-naive HIV-infected patients with chronic hepatitis C coinfection from two HIV treatment centers in Vietnam. Patients will be randomized to receive either raltegravir or efavirenz, both in combination of tenofovir and emtricitabine, as first-line HIV therapy over a period of 72 weeks. The primary endpoint is the rate of alanine aminotransferase (ALT) elevation during the 72 week study period. Secondary endpoints include rates of virological suppression, CD4 count change, numbers of AIDS events and death, rates of fasting glucose and cholesterol measures, neurocognitive function and levels of immune activation. Patients will be followed monthly for the first 3 months and every 3 months thereafter. At the end of the trial period, patients will be transferred to the National HIV treatment program for continuation of HIV therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltegravir based therapy | Experimental | Drug: RaltegravirEmtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily |
| Efavirenz based therapy | Active comparator | Drug: EfavirenzEmtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaltegravirAlso: IsentressEmtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily | Drug | Raltegravir based therapy |
| EfavirenzAlso: SustivaEmtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily | Drug | Efavirenz based therapy |
Primary outcome
Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations
Time frame: over week 72
To estimate the rates of grade 2*and higher ALT elevations in the two regimens.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD will be shared with other researchers upon request following the publication of the data. Researchers will contact the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Van Vinh Chau Nguyen, MD, PhD principal investigator
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Cecilia M Shikuma, M.D. principal investigator
University of Hawaii - Hawaii Center for AIDS (HICFA)
Thuy Le, M.D. study director
University of Hawaii, Oxford University Clinical Research Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Raltegravir and Efavirenz in people with Hepatitis C, Chronic and HIV Infection, run by University of Hawaii at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations (time frame: over week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.