HIV-1 InfectionPhase 4NCT01989910
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
A Phase 4 study testing Raltegravir and Efavirenz in people with HIV-1 Infection, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Raltegravir and Efavirenz
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2013to Dec 2017
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are infected with HIV-1
- Patients have not yet received any treatment for HIV
- Patients with HIV viral RNA exceeds 5000 copies per ml
- Ages at least 20 years
Who cannot join
- Patients with acute or decompensated chronic hepatitis
- Patients with chronic hepatitis and serum aminotransferase concentrations are more than five times the upper limit of the normal range
- Patients with renal insufficiency (need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range
- Patients with any medical disorder that the use of study medications is contraindicated
- Pregnant or breastfeeding women
- Patients who are lack of expectation to maintain assigned study medication during study period
- Patients who have received therapy with investigational drugs in the previous 3 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Infectious Diseases, Taipei Veterans General Hospital
Taipei, 11217
About this study
Official title: An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Efficacy and Safety of Raltegravir-based Versus Efavirenz-based Combination Therapy in Treatment-naïve Patients With HIV-1 Infection
A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection.
Read the detailed description
A single-center, prospective, randomized, open label, parallel study to compare the efficacy and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside reverse-transcriptase inhibitors(NRTIs) backbone combination therapy in treatment-naïve patients with HIV-1 infection.
- Conditions
- HIV-1 Infection
- Being tested
- Raltegravir, Efavirenz
- Keywords
- Efavirenz, Raltegravir, Combination antiretroviral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Also called Isentress
Raltegravir 400mg oral twice daily
EfavirenzDrug
Also called Stocrit
Efavirenz 600mg oral at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir | Active comparator | Raltegravir 400mg oral twice daily Receives: Drug: Efavirenz |
| Efavirenz | Active comparator | Efavirenz 600mg oral at bedtime Receives: Drug: Raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.
Virological response to achieve HIV RNA copies <20 copies/mL at week 48 of both arms.
Measured: At week 48 of both arms
Secondary outcomes (3)
The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.
Virological response to achieve HIV RNA copies <400 copies/mL at week 48 of both arms.
Measured: At week 48 of both arms
The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms.
The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms.
Measured: At week 48 of both arms.
The Proportion of Treatment Failure at Week 48 for Both Arms.
The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms.
Measured: At week 48 of both arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2017
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wing Wai Wong, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989910
- Sponsor's protocol ID
- MSD-MISP-39299
- Other IDs
- TVGH-IRB-2013-07-030B
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2013
- Last updated
- 25 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, Zhao J, Xu X, Williams-Diaz A, Rodgers AJ, Barnard RJ, Miller MD, DiNubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK investigators. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009 Sep 5;374(9692):796-806. doi: 10.1016/S0140-6736(09)60918-1. Epub 2009 Aug 3.
PubMed 19647866Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.
PubMed 20085491Young B, Vanig T, Dejesus E, Hawkins T, St Clair M, Yau L, Ha B, Shield Study Team. A pilot study of abacavir/lamivudine and raltegravir in antiretroviral-naive HIV-1-infected patients: 48-week results of the SHIELD trial. HIV Clin Trials. 2010 Sep-Oct;11(5):260-9. doi: 10.1310/hct1105-260.
PubMed 21126956
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Efficacy and Safety of Raltegravir-based Versus Efavirenz-based Combination Therapy in Treatment-naïve Patients With HIV-1 Infection
- ClinicalTrials.gov ID
- NCT01989910
- Acronym / sponsor ID
- MSD-MISP-39299
- Conditions
- HIV-1 Infection
- Keywords
- Efavirenz, Raltegravir, Combination antiretroviral therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Posted 25 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection.
Detailed description
A single-center, prospective, randomized, open label, parallel study to compare the efficacy and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside reverse-transcriptase inhibitors(NRTIs) backbone combination therapy in treatment-naïve patients with HIV-1 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltegravir | Active comparator | Drug: EfavirenzRaltegravir 400mg oral twice daily |
| Efavirenz | Active comparator | Drug: RaltegravirEfavirenz 600mg oral at bedtime |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who are infected with HIV-1
- Patients have not yet received any treatment for HIV
- Patients with HIV viral RNA exceeds 5000 copies per ml
- Ages at least 20 years
Key exclusion criteria (7 listed)
- Patients with acute or decompensated chronic hepatitis
- Patients with chronic hepatitis and serum aminotransferase concentrations are more than five times the upper limit of the normal range
- Patients with renal insufficiency (need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range
- Patients with any medical disorder that the use of study medications is contraindicated
- Pregnant or breastfeeding women
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: IsentressRaltegravir 400mg oral twice daily | Drug | Efavirenz |
| EfavirenzAlso: StocritEfavirenz 600mg oral at bedtime | Drug | Raltegravir |
Primary outcome
The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.
Time frame: At week 48 of both arms
Virological response to achieve HIV RNA copies <20 copies/mL at week 48 of both arms.
3 secondary outcomes
The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.
Time frame: At week 48 of both arms
The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms.
Time frame: At week 48 of both arms.
The Proportion of Treatment Failure at Week 48 for Both Arms.
Time frame: At week 48 of both arms
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19647866Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, Zhao J, Xu X, Williams-Diaz A, Rodgers AJ, Barnard RJ, Miller MD, DiNubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK investigators. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009 Sep 5;374(9692):796-806. doi: 10.1016/S0140-6736(09)60918-1. Epub 2009 Aug 3.
- Background: PubMed 20085491Steigbigel RT, Cooper DA, Teppler H, Eron JJ, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Katlama C, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Clotet B, Zhao J, Wan H, Rhodes RR, Strohmaier KM, Barnard RJ, Isaacs RD, Nguyen BY; BENCHMRK Study Teamsa. Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. Clin Infect Dis. 2010 Feb 15;50(4):605-12. doi: 10.1086/650002.
- Background: PubMed 21126956Young B, Vanig T, Dejesus E, Hawkins T, St Clair M, Yau L, Ha B, Shield Study Team. A pilot study of abacavir/lamivudine and raltegravir in antiretroviral-naive HIV-1-infected patients: 48-week results of the SHIELD trial. HIV Clin Trials. 2010 Sep-Oct;11(5):260-9. doi: 10.1310/hct1105-260.
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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.
Wing Wai Wong, MD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site 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 HIV-1 Infection, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 7 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 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 25 Feb 2019). 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?
The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms. (time frame: At week 48 of both arms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01989910, which also lists 3 linked publications.
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 25 Feb 2019.