HIV/AIDSNCT03405194
Same-Day Treatment With Genvoya vs. EFV/TDF/3TC
A study testing Elvitegravir, Cobicistat, TAF, FTC and Efavirenz, TDF, and 3TC in people with HIV/AIDS, run by Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic.
Trial summary
Randomized, open-label study comparing Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine (Genvoya) vs. Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine (EFV-TDF-3TC) in patients starting ART on the day of HIV diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Elvitegravir, Cobicistat, TAF, FTC and Efavirenz, TDF, and 3TC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 1 Jul 2020
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documentation of positive HIV status (test conducted at GHESKIO);
- At least 18 years of age;
- Unaware of HIV diagnosis prior to date of enrollment, and ART-naïve;
- Ability and willingness to give written informed consent;
- Ready to initiate same-day ART, according to two criteria: (1) HIV medication readiness questionnaire; and (2) social worker assessment;
- WHO Stage 1 or 2 disease, as defined by the following conditions: asymptomatic; persistent generalized lymphadenopathy; unexplained weight loss (under 10%); recurrent upper respiratory tract infections; herpes zoster; angular chelitis; recurrent oral ulcerations; papular pruritic eruptions; seborrheic dermatitis; or fungal nail infections.
- Female participants may be enrolled if they are either: (1) post-menopausal; (2) physically incapable of becoming pregnant due to tubal ligation, hysterectomy, or bilateral oophorectomy; or (3) are of childbearing potential, and agree to use one of the following methods to avoid pregnancy throughout the duration of the study:
- Complete abstinence from intercourse; Double barrier method, such as male condom/spermicide, male condom/diaphragm, or diaphragm/spermicide; Hormonal contraception plus a barrier method; Intrauterine device (IUD); Male partner sterilization (if participant has only one sexual partner);
Who cannot join
- Pregnancy or breastfeeding at the screening visit;
- Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician;
- World Health Organization Stage 3 or 4 disease, as defined by the following conditions: unexplained severe weight loss (over 10% of presumed or measured body weight); unexplained chronic diarrhea for longer than 1 month; unexplained persistent fever (intermittent or constant for longer than 1 month); persistent oral candidiasis; oral hairy leukoplakia; pulmonary tuberculosis; severe bacterial infections (e.g. pneumonia, empyema, meningitis, pyomyositis, bone or joint infection, bacteremia, severe pelvic inflammatory disease); or acute necrotizing ulcerative stomatitis, gingivitis or periodontitis.
- Clinical evidence of cirrhosis (ascites or encephalopathy);
- Anticipated need for hepatitis C therapy during the study period;
- Baseline CrCl <30 mL/minute by the Cockcroft-Gault equation (late exclusion, as creatinine results will not be available at the time of enrollment);
- Either the K65R mutation or more than 3 thymidine analogue mutations on baseline resistance testing (late exclusions, after baseline resistance results are available).
- Planning to transfer care to another clinic during the study period;
About this study
Official title: An Open-Label, Randomized Comparison of Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine Versus Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine in Patients Starting Antiretroviral Therapy on the Day of HIV Diagnosis
Randomized, open-label study comparing Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine (Genvoya) vs. Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine (EFV-TDF-3TC) in patients starting ART on the day of HIV diagnosis.
Read the detailed description
Patients with WHO Stage 1 or 2 disease at HIV diagnosis will be randomized in a 1:1 ratio to either the Genvoya group or the EFV-TDF-3TC group. ART will be initiated on the day of HIV diagnosis. Participants who are found to have a contraindication to their assigned treatment regimen will change ART, and be classified as a failure for their assigned treatment arm. Participants in the EFV-TDF-3TC group with CrCl of 30-50 mL/minute, or with baseline mutations that significantly reduce the susceptibility of EFV will switch to Genvoya. Participants in the Genvoya group who are diagnosed with TB after enrollment will be switched to an ART regimen that can be administered with rifampin. If the study physician determines that a treatment change is indicated due to intolerability or side effects, the relevant clinical data will be presented to a safety committee that is blinded to group assignment. The ART regimen will be changed if the safety committee determines that it is indicated, and the participant will be considered a failure to their assigned treatment group. Patients will be followed for 48 weeks.
- Conditions
- HIV/AIDS
- Being tested
- Elvitegravir, Cobicistat, TAF, FTC, Efavirenz, TDF, and 3TC
- Keywords
- HIV/AIDS, Same-Day ART, Genvoya, Efavirenz
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elvitegravir, Cobicistat, TAF, FTCDrug
Started on day of HIV diagnosis
Efavirenz, TDF, and 3TCDrug
Started on day of HIV diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Elvitegravir-Cobicistat-TAF-FTC | Experimental | Elvitegravir 150mg po QD Cobicistat 150 mg po QD TAF 10 mg po QD FTC 200 mg QD Receives: Drug: Elvitegravir, Cobicistat, TAF, FTC |
| EFV-TDF-3TC | Active comparator | EFV 600 mg po QD TDF 300 mg po QD 3TC 300 mg po QD Receives: Drug: Efavirenz, TDF, and 3TC |
What is being measured
The primary outcome is the main question the study is designed to answer.
48-week viral suppression
To compare the proportion of participants who are retained in care with a plasma HIV-1 RNA level <200 copies/ml
Measured: 48 weeks after enrollment
Secondary outcomes (9)
12-week viral suppression
Proportion of participants who are retained in care with a plasma HIV-1 RNA level <200 copies/ml
Measured: 12 weeks after enrollment
Baseline resistance to ART medications
Genotypic resistance to EFV and/or nucleoside reverse transcriptase inhibitors
Measured: Baseline
Change in CD4 count
Median change in CD4 count over the study period (baseline to 48 weeks)
Measured: 48 weeks after enrollment
Virologic failure
Proportion of patients meeting the WHO definition for ART treatment failure over the study period
Measured: 48 weeks after enrollment
Adverse events
Proportion of participants with a new Division of AIDS Grade 3 or 4 adverse event or laboratory abnormality that is at least a one-grade increase from baseline
Measured: 48 weeks after HIV testing
Neurologic or psychiatric adverse event
Proportion of participants with a new Division of AIDS Grade 1 to 4 neurologic or psychiatric disorder that is at least a one-grade increase from baseline
Measured: 48 weeks
Sleep Quality
Mean scores on the Pittsburgh Sleep Quality Index
Measured: 4, 12, 24, and 48 weeks after enrollment
Depression
Mean scores on the Patient Health Questionnaires (PHQ-9) Questionnaire
Measured: 4, 12, 24, and 48 weeks after enrollment
Change in ART drugs
Proportion of participants who discontinue any drug in the original ART regimen
Measured: 48 weeks after HIV testing after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 May 2018 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Why it stopped: Haiti gained access to dolutegravir as first-line ART, so we cancelled the study before any patient was enrolled (we didn't want SOC group to receive EFV)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Same-Day ART with Genvoya vs. EFV/TDF/3TC
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Brigham and Women's Hospital, Weill Medical College of Cornell University, Analysis Group, Inc.
- Responsible party
- Sponsor
- Investigators
- Jean W Pape, MD, Principal investigator, Haitian Group for the Study of Kaposi's Sarcoma and OpportunisticSerena P Koenig, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405194
- Sponsor's protocol ID
- IN-US-292-4500
- Status last verified
- Mar 2020
- First submitted
- 24 Dec 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized Comparison of Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine Versus Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine in Patients Starting Antiretroviral Therapy on the Day of HIV Diagnosis
- ClinicalTrials.gov ID
- NCT03405194
- Acronym / sponsor ID
- IN-US-292-4500
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, Same-Day ART, Genvoya, Efavirenz
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Haiti gained access to dolutegravir as first-line ART, so we cancelled the study before any patient was enrolled (we didn't want SOC group to receive EFV)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Haitian Group for the Study of Kaposi's Sarcoma and OpportunisticUniversity, hospital or other
- Collaborators
- Gilead Sciences, Brigham and Women's Hospital, Weill Medical College of Cornell University, Analysis Group, Inc.
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 23 Jan 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.
Randomized, open-label study comparing Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine (Genvoya) vs. Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine (EFV-TDF-3TC) in patients starting ART on the day of HIV diagnosis.
Detailed description
Patients with WHO Stage 1 or 2 disease at HIV diagnosis will be randomized in a 1:1 ratio to either the Genvoya group or the EFV-TDF-3TC group. ART will be initiated on the day of HIV diagnosis. Participants who are found to have a contraindication to their assigned treatment regimen will change ART, and be classified as a failure for their assigned treatment arm. Participants in the EFV-TDF-3TC group with CrCl of 30-50 mL/minute, or with baseline mutations that significantly reduce the susceptibility of EFV will switch to Genvoya. Participants in the Genvoya group who are diagnosed with TB after enrollment will be switched to an ART regimen that can be administered with rifampin. If the study physician determines that a treatment change is indicated due to intolerability or side effects, the relevant clinical data will be presented to a safety committee that is blinded to group assignment. The ART regimen will be changed if the safety committee determines that it is indicated, and the participant will be considered a failure to their assigned treatment group. Patients will be followed for 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Same-Day ART with Genvoya vs. EFV/TDF/3TC
| Arm | Type | Receives |
|---|---|---|
| Elvitegravir-Cobicistat-TAF-FTC | Experimental | Drug: Elvitegravir, Cobicistat, TAF, FTCElvitegravir 150mg po QD Cobicistat 150 mg po QD TAF 10 mg po QD FTC 200 mg QD |
| EFV-TDF-3TC | Active comparator | Drug: Efavirenz, TDF, and 3TCEFV 600 mg po QD TDF 300 mg po QD 3TC 300 mg po QD |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documentation of positive HIV status (test conducted at GHESKIO);
- At least 18 years of age;
- Unaware of HIV diagnosis prior to date of enrollment, and ART-naïve;
- Ability and willingness to give written informed consent;
- Ready to initiate same-day ART, according to two criteria: (1) HIV medication readiness questionnaire; and (2) social worker assessment;
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding at the screening visit;
- Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician;
- World Health Organization Stage 3 or 4 disease, as defined by the following conditions: unexplained severe weight loss (over 10% of presumed or measured body weight); unexplained chronic diarrhea for longer than 1 month; unexplained persistent fever (intermittent or constant for longer than 1 month); persistent oral candidiasis; oral hairy leukoplakia; pulmonary tuberculosis; severe bacterial infections (e.g. pneumonia, empyema, meningitis, pyomyositis, bone or joint infection, bacteremia, severe pelvic inflammatory disease); or acute necrotizing ulcerative stomatitis, gingivitis or periodontitis.
- Clinical evidence of cirrhosis (ascites or encephalopathy);
- Anticipated need for hepatitis C therapy during the study period;
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 |
|---|---|---|
| Elvitegravir, Cobicistat, TAF, FTCStarted on day of HIV diagnosis | Drug | Elvitegravir-Cobicistat-TAF-FTC |
| Efavirenz, TDF, and 3TCStarted on day of HIV diagnosis | Drug | EFV-TDF-3TC |
Primary outcome
48-week viral suppression
Time frame: 48 weeks after enrollment
To compare the proportion of participants who are retained in care with a plasma HIV-1 RNA level <200 copies/ml
9 secondary outcomes
12-week viral suppression
Time frame: 12 weeks after enrollment
Baseline resistance to ART medications
Time frame: Baseline
Change in CD4 count
Time frame: 48 weeks after enrollment
Virologic failure
Time frame: 48 weeks after enrollment
Adverse events
Time frame: 48 weeks after HIV testing
Neurologic or psychiatric adverse event
Time frame: 48 weeks
Sleep Quality
Time frame: 4, 12, 24, and 48 weeks after enrollment
Depression
Time frame: 4, 12, 24, and 48 weeks after enrollment
Change in ART drugs
Time frame: 48 weeks after HIV testing after enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
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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.
Jean W Pape, MD principal investigator
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Serena P Koenig, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Elvitegravir, Cobicistat, TAF, FTC and Efavirenz, TDF, and 3TC in people with HIV/AIDS, run by Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic.
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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
48-week viral suppression (time frame: 48 weeks after enrollment). 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 18 Mar 2020.