HIV InfectionsPhase 3NCT03595709
Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) in Combo Tablet for Patients Receiving Atripla With Viral Suppression in Taiwan
A Phase 3 study testing 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) in people with HIV Infections, run by Yu-Jay Corp. at 2 sites in Taiwan.
Trial summary
Prospective, Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) Plus Tenofovir Disoproxil Fumarate (TDF) and Lamivudine in a Fixed-Dose Combination Tablet (Combo) for Patients Receiving Co-Formulated TDF, Emtricitabine and Efavirenz (Atripla) with Viral Suppression in Taiwan Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTaiwan
- Study dates
- 6 Dec 2018to 16 Jul 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are receiving co-formulated TDF/ FTC/ EFV (600 mg) and have achieved an undetectable plasma viral load (<50 copies/mL) for 6 months or longer at screening visit.
- Having C12 EFV of 1 mg/L or greater at screening.
- (C12 EFV will be determined by using blood sample collected 12 ± 1 hour after previous dosing of co-formulated TDF/ FTC/ EFV (600 mg).
- No known treatment failure to regimens containing TDF, 3TC or FTC, plus EFV.
- Infected with HIV harboring no known resistance-associated mutations to EFV, TDF, 3TC or FTC.
- No known allergies to EFV, TDF, 3TC or FTC.
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- Aged ≧20 years.
- Calculated creatinine clearance (ClCr) ≥ 50 mL/min (Cockcroft-Gault formula).
- Provision of written informed consent.
Who cannot join
- The following laboratory values:
- Absolute neutrophil count (ANC) <500 cells/μL
- Hemoglobin <7.0 g/dL
- Platelet count <50,000 cells/μL
- Serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >5x upper limit of normal (ULN)
- Pregnant women or nursing mothers.
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- Active opportunistic or malignant disease not under adequate control.
- Use of immunomodulators within 30 days prior to screening visit.
- Use any of the prohibited medications: bepridil, astemizole, terfenadine, dihydroergotamine, ergometrine, ergotamine, systemic cytotoxic chemotherapy, amodiaquine, pimozide, midazolam, triazolam, cisapride、St John's Wort、 Elbasvir/Grazoprevir and Simeprevir.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
E-Da Hospital
Kaohsiung City, 82445
National Taiwan University Hospital
Taipei
About this study
Official title: Prospective, Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) Plus Tenofovir Disoproxil Fumarate (TDF) and Lamivudine in a Fixed-Dose Combination Tablet (Combo) for Patients Receiving Co-Formulated TDF, Emtricitabine and Efavirenz (Atripla) With Viral Suppression in Taiwan
Prospective, Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) Plus Tenofovir Disoproxil Fumarate (TDF) and Lamivudine in a Fixed-Dose Combination Tablet (Combo) for Patients Receiving Co-Formulated TDF, Emtricitabine and Efavirenz (Atripla) with Viral Suppression in Taiwan
Read the detailed description
Efavirenz (EFV) is the most widely used non-nucleoside reverse transcriptase inhibitor (NNRTI). The recommended dose of EFV is 600 mg daily; however, a phase II study showed no significant difference in viral suppression rates across the different EFV groups (200 mg, 400 mg, and 600 mg) at 24 weeks. The week 96 analysis of ENCORE 1 study confirmed the durable virological non-inferiority of EFV 400 mg to the standard 600 mg dose when given as initial therapy with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Fewer EFV-related adverse events (AEs) and fewer treatment discontinuations were also observed in the reduced dose group. The efficacy and safety findings provide robust evidence to redefine the EFV dose for HIV treatment.
- Conditions
- HIV Infections
- Being tested
- 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg)
- Keywords
- Efavirenz, HIV Infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg)Drug
Also called non applicable
All eligible subjects will receive 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) once daily for 24 weeks orally on empty stomach before bedtime. If the event of toxicity or tolerability issues requires a change from study drug, switching to the best available treatment will be recommended.
| Study group | Role | What they receive |
|---|---|---|
| combined tablet (EFV 400,TDF 300, 3TC 300) | Experimental | All eligible subjects will receive 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) once daily for 24 weeks orally on empty stomach before bedtime. If the event of toxicity or tolerability issues requires a change from study drug, switching to the best available treatment will be recommended. Receives: Drug: 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
C12 EFV concentration
The proportion of subjects achieving C12 EFV concentration >1.0 mg/L at Week 4.
Measured: Week 4
Secondary outcomes (5)
HIV-1 RNA load
The proportion of subjects with undetectable plasma HIV-1 RNA load (<50 copies/mL) at Week 12
Measured: Week 12
HIV-1 RNA load
The proportion of subjects with undetectable plasma HIV-1 RNA load (<50 copies/mL) at Week 24
Measured: Week 24
EFV concentration
The mean changes from baseline in C12 EFV concentration at Week 4.
Measured: Week 4
CD4+ T cell count
The mean changes from baseline in CD4+ T cell count at Week 12.
Measured: Week 12
CD4+ T cell count
The mean changes from baseline in CD4+ T cell count at Week 24.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start6 Dec 2018
- Primary completion6 Mar 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open-label
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu-Jay Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hsin-Yun Sun, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595709
- Sponsor's protocol ID
- YJ14001-COMBO-201801
- Status last verified
- Feb 2020
- First submitted
- 2 Jul 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) Plus Tenofovir Disoproxil Fumarate (TDF) and Lamivudine in a Fixed-Dose Combination Tablet (Combo) for Patients Receiving Co-Formulated TDF, Emtricitabine and Efavirenz (Atripla) With Viral Suppression in Taiwan
- ClinicalTrials.gov ID
- NCT03595709
- Acronym / sponsor ID
- YJ14001-COMBO-201801
- Conditions
- HIV Infections
- Keywords
- Efavirenz, HIV Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yu-Jay Corp.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, Therapeutic Drug Monitoring Study of Reduced-Dose Efavirenz (400 mg) Plus Tenofovir Disoproxil Fumarate (TDF) and Lamivudine in a Fixed-Dose Combination Tablet (Combo) for Patients Receiving Co-Formulated TDF, Emtricitabine and Efavirenz (Atripla) with Viral Suppression in Taiwan
Detailed description
Efavirenz (EFV) is the most widely used non-nucleoside reverse transcriptase inhibitor (NNRTI). The recommended dose of EFV is 600 mg daily; however, a phase II study showed no significant difference in viral suppression rates across the different EFV groups (200 mg, 400 mg, and 600 mg) at 24 weeks. The week 96 analysis of ENCORE 1 study confirmed the durable virological non-inferiority of EFV 400 mg to the standard 600 mg dose when given as initial therapy with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC). Fewer EFV-related adverse events (AEs) and fewer treatment discontinuations were also observed in the reduced dose group. The efficacy and safety findings provide robust evidence to redefine the EFV dose for HIV treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open-label
| Arm | Type | Receives |
|---|---|---|
| combined tablet (EFV 400,TDF 300, 3TC 300) | Experimental | Drug: 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg)All eligible subjects will receive 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) once daily for 24 weeks orally on empty stomach before bedtime. If the event of toxicity or tolerability issues requires a change from study drug, switching to the best available treatment will be recommended. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who are receiving co-formulated TDF/ FTC/ EFV (600 mg) and have achieved an undetectable plasma viral load (<50 copies/mL) for 6 months or longer at screening visit.
- Having C12 EFV of 1 mg/L or greater at screening.
- (C12 EFV will be determined by using blood sample collected 12 ± 1 hour after previous dosing of co-formulated TDF/ FTC/ EFV (600 mg).
- No known treatment failure to regimens containing TDF, 3TC or FTC, plus EFV.
- Infected with HIV harboring no known resistance-associated mutations to EFV, TDF, 3TC or FTC.
Key exclusion criteria (9 listed)
- The following laboratory values:
- Pregnant women or nursing mothers.
- Active opportunistic or malignant disease not under adequate control.
- Use of immunomodulators within 30 days prior to screening visit.
- Use any of the prohibited medications: bepridil, astemizole, terfenadine, dihydroergotamine, ergometrine, ergotamine, systemic cytotoxic chemotherapy, amodiaquine, pimozide, midazolam, triazolam, cisapride、St John's Wort、 Elbasvir/Grazoprevir and Simeprevir.
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 |
|---|---|---|
| 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg)Also: non applicableAll eligible subjects will receive 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) once daily for 24 weeks orally on empty stomach before bedtime. If the event of toxicity or tolerability issues requires a change from study drug, switching to the best available treatment will be recommended. | Drug | combined tablet (EFV 400,TDF 300, 3TC 300) |
Primary outcome
C12 EFV concentration
Time frame: Week 4
The proportion of subjects achieving C12 EFV concentration >1.0 mg/L at Week 4.
5 secondary outcomes
HIV-1 RNA load
Time frame: Week 12
HIV-1 RNA load
Time frame: Week 24
EFV concentration
Time frame: Week 4
CD4+ T cell count
Time frame: Week 12
CD4+ T cell count
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Hsin-Yun Sun, MD principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) in people with HIV Infections, run by Yu-Jay Corp. at 2 sites 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 9 inclusion and 9 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 7 Feb 2020. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
C12 EFV concentration (time frame: Week 4). 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 7 Feb 2020.