Status:
WITHDRAWN
Same-Day Treatment With Genvoya vs. EFV/TDF/3TC
Lead Sponsor:
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Collaborating Sponsors:
Gilead Sciences
Brigham and Women's Hospital
Conditions:
HIV/AIDS
Eligibility:
All Genders
18-99 years
Phase:
NA
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 A...
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. Parti...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03405194
Start Date
May 1 2018
End Date
July 1 2020
Last Update
March 18 2020
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