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

NCT03405194 | Withdrawn DMC

• 1 other identifier: IN-US-292-4500
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV/AIDS

Keywords

HIV/AIDS; Same-Day ART; Genvoya; Efavirenz

Outcome Measures

Primary Outcomes (1)

• 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

  48 weeks after enrollment

Secondary Outcomes (9)

• 12-week viral suppression

  12 weeks after enrollment

• Baseline resistance to ART medications

  Baseline

• Change in CD4 count

  48 weeks after enrollment

• Virologic failure

  48 weeks after enrollment

• Adverse events

  48 weeks after HIV testing

Study Arms (2)

Elvitegravir-Cobicistat-TAF-FTC

EXPERIMENTAL

Elvitegravir 150mg po QD Cobicistat 150 mg po QD TAF 10 mg po QD FTC 200 mg QD

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

Drug: Efavirenz, TDF, and 3TC

Interventions

Elvitegravir, Cobicistat, TAF, FTC DRUG

Started on day of HIV diagnosis

Elvitegravir-Cobicistat-TAF-FTC

Efavirenz, TDF, and 3TC DRUG

Started on day of HIV diagnosis

EFV-TDF-3TC

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;
• Planning to transfer care to another clinic during the study period;

Sponsors & Collaborators

• Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic: lead
• Gilead Sciences: collaborator
• Brigham and Women's Hospital: collaborator
• Weill Medical College of Cornell University: collaborator
• Analysis Group, Inc.: collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

elvitegravir; Cobicistat; Racivir; efavirenz

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jean W Pape, MD

  Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

  PRINCIPAL INVESTIGATOR

• Serena P Koenig, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Same-Day ART with Genvoya vs. EFV/TDF/3TC

Study Record Dates

• First Submitted: December 24, 2017
• First Posted: January 23, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03