Same-Day Treatment With Genvoya vs. EFV/TDF/3TC

• Status: Withdrawn
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
• Collaborators: Analysis Group, Inc.; Brigham and Women's Hospital; Gilead Sciences; Weill Medical College of Cornell University
• Treatments: Cobicistat; Efavirenz; Elvitegravir; Tenofovir

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;