Clinical trial NCT03405194: Same-Day Treatment With Genvoya vs. EFV/TDF/3TC
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HIV/AIDS
Keywords: HIV/AIDS
Same-Day ART
Genvoya
Efavirenz
Lead sponsor: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
name: Brigham and Women's Hospital
name: Weill Medical College of Cornell University
name: Analysis Group, Inc.
First posted: 2018-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Same-Day ART with Genvoya vs. EFV/TDF/3TC
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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);

Exclusion Criteria:

* 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;

Primary outcomes:
measure: 48-week viral suppression
timeFrame: 48 weeks after enrollment
Secondary outcomes:
measure: 12-week viral suppression
timeFrame: 12 weeks after enrollment
measure: Baseline resistance to ART medications
timeFrame: Baseline
measure: Change in CD4 count
timeFrame: 48 weeks after enrollment
measure: Virologic failure
timeFrame: 48 weeks after enrollment
measure: Adverse events
timeFrame: 48 weeks after HIV testing
measure: Neurologic or psychiatric adverse event
timeFrame: 48 weeks
measure: Sleep Quality
timeFrame: 4, 12, 24, and 48 weeks after enrollment
measure: Depression
timeFrame: 4, 12, 24, and 48 weeks after enrollment
measure: Change in ART drugs
timeFrame: 48 weeks after HIV testing after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
name: Jean W Pape, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Serena P Koenig, MD
role: PRINCIPAL_INVESTIGATOR
References: