Phase
Condition
Aids And Aids Related Infections
Hiv Infections
Hiv/aids
Treatment
ISL/ULO
BIC/FTC/TAF
Placebo for BIC/FTC/TAF
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL.
Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies/mL.
Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200cells/mm^3.
Is naïve to antiretroviral therapy (ART), defined as having received no priortherapy with any antiretroviral agent following a diagnosis of HIV 1 infection.
Exclusion
Exclusion Criteria:
Has human immunodeficiency virus type 2 (HIV-2) infection.
Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-definingopportunistic infection.
Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
Has a history of malignancy ≤5 years prior to providing documented informed consentexcept for adequately treated basal cell or squamous cell skin cancer, in situcervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.
Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration anytime prior to Day 1.
Study Design
Connect with a study center
Fundación Huesped ( Site 3100)
CABA, Buenos Aires C1427CEA
ArgentinaActive - Recruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102)
Caba, Buenos Aires C1425AGC
ArgentinaActive - Recruiting
Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)
Mar del Plata, Buenos Aires B7600FZN
ArgentinaActive - Recruiting
Fundación IDEAA ( Site 3101)
Buenos Aires, Buenos Aires F.D. C1405CKC
ArgentinaActive - Recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105)
San Miguel de Tucumán, Tucumán Province T4000IHE
ArgentinaActive - Recruiting
Spectrum Health ( Site 3307)
Vancouver, British Columbia V6Z 2T1
CanadaActive - Recruiting
Spectrum Health ( Site 3307)
Vancouver 6173331, British Columbia 5909050 V6Z 2T1
CanadaSite Not Available
Gestion clinique médicale l'Actuel ( Site 3303)
Montreal, Quebec H2L 4P9
CanadaActive - Recruiting
Gestion clinique médicale l'Actuel ( Site 3303)
Montreal 6077243, Quebec 6115047 H2L 4P9
CanadaSite Not Available
Bordeaux University Hospital - Pellegrin ( Site 3605)
Bordeaux, Gironde 33000
FranceActive - Recruiting
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608)
Toulouse, Haute-Garonne 31059
FranceActive - Recruiting
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606)
Nantes, Pays de la Loire Region 44093
FranceActive - Recruiting
HOPITAL DE LA CROIX ROUSSE ( Site 3613)
Lyon, Rhone 69317
FranceActive - Recruiting
Hôpital Avicenne ( Site 3602)
Bobigny, Île-de-France Region 93000
FranceActive - Recruiting
Hôpital Bichat - Claude-Bernard ( Site 3601)
Paris, Île-de-France Region 75018
FranceActive - Recruiting
Hôpital Saint-Louis ( Site 3600)
Paris, Île-de-France Region 75010
FranceActive - Recruiting
CELAN,S.A ( Site 3802)
Guatemala City, 01010
GuatemalaActive - Recruiting
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801)
Guatemala City, 01009
GuatemalaActive - Recruiting
MEDI-K ( Site 3803)
Guatemala City, 01009
GuatemalaActive - Recruiting
CELAN,S.A ( Site 3802)
Guatemala City 3598132, 01010
GuatemalaSite Not Available
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801)
Guatemala City 3598132, 01009
GuatemalaActive - Recruiting
MEDI-K ( Site 3803)
Guatemala City 3598132, 01009
GuatemalaActive - Recruiting
Morales Vargas Centro de Investigacion, S.C. ( Site 4502)
León, Guanajuato 37000
MexicoActive - Recruiting
Arké SMO S.A de C.V ( Site 4505)
Veracruz, 91910
MexicoActive - Recruiting
Wentworth Hospital ( Site 4303)
Durban, KwaZulu-Natal 4052
South AfricaActive - Recruiting
Be Part Yoluntu Centre ( Site 4300)
Mbekweni, Paarl, Western Cape 7646
South AfricaActive - Recruiting
Hospital Universitario La Paz ( Site 3404)
Madrid, Madrid, Comunidad de 28029
SpainActive - Recruiting
Consorcio Hospital General Universitario de Valencia ( Site 3406)
Valencia, Valenciana, Comunitat 46014
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron ( Site 3402)
Barcelona, 08035
SpainActive - Recruiting
Complejo Hospitalario Virgen De La Victoria ( Site 3409)
Málaga, 29010
SpainActive - Recruiting
Ruane Clinical Research Group, Inc. ( Site 1513)
Los Angeles, California 90036
United StatesActive - Recruiting
Vivent Health ( Site 1519)
Denver, Colorado 80246
United StatesActive - Recruiting
Vivent Health ( Site 1519)
Denver 5419384, Colorado 5417618 80246
United StatesSite Not Available
Whitman-Walker Institute ( Site 1538)
Washington D.C., District of Columbia 20032
United StatesActive - Recruiting
Whitman-Walker Institute ( Site 1538)
Washington D.C. 4140963, District of Columbia 4138106 20032
United StatesSite Not Available
Midway Immunology and Research Center ( Site 1503)
Ft. Pierce, Florida 34982
United StatesActive - Recruiting
CAN Community Health- Miami Gardens ( Site 1549)
Miami, Florida 33055
United StatesSite Not Available
CAN Community Health- Miami Gardens ( Site 1549)
Miami Gardens, Florida 33055
United StatesActive - Recruiting
Orlando Immunology Center ( Site 1501)
Orlando, Florida 32803
United StatesActive - Recruiting
CAN Community Health ( Site 1510)
Sarasota, Florida 34237
United StatesActive - Recruiting
Triple O Research Institute ( Site 1505)
West Palm Beach, Florida 33407
United StatesActive - Recruiting
Midway Immunology and Research Center ( Site 1503)
Ft. Pierce 4156018, Florida 4155751 34982
United StatesSite Not Available
Midway Immunology and Research Center (1503)
Ft. Pierce 4156018, Florida 4155751 34982
United StatesActive - Recruiting
CAN Community Health- Miami Gardens ( Site 1549)
Miami 4164138, Florida 4155751 33055
United StatesSite Not Available
Orlando Immunology Center ( Site 1501)
Orlando 4167147, Florida 4155751 32803
United StatesSite Not Available
CAN Community Health ( Site 1510)
Sarasota 4172131, Florida 4155751 34237
United StatesSite Not Available
Triple O Research Institute ( Site 1505)
West Palm Beach 4177887, Florida 4155751 33407
United StatesSite Not Available
Metro Infectious Diseases Consultants L.L.C. ( Site 1509)
Decatur, Georgia 30033
United StatesActive - Recruiting
Mercer university, Department of internal medicine-Clinical Research ( Site 1512)
Macon, Georgia 31201
United StatesActive - Recruiting
Metro Infectious Diseases Consultants L.L.C. ( Site 1509)
Decatur 4191124, Georgia 4197000 30033
United StatesSite Not Available
Mercer university, Department of internal medicine-Clinical Research ( Site 1512)
Macon 4207400, Georgia 4197000 31201
United StatesSite Not Available
Henry Ford Hospital ( Site 1535)
Detroit, Michigan 48202
United StatesActive - Recruiting
KC CARE Health Center ( Site 1506)
Kansas City, Missouri 64111
United StatesActive - Recruiting
KC CARE Health Center ( Site 1506)
Kansas City 4393217, Missouri 4398678 64111
United StatesSite Not Available
ID Care ( Site 1507)
Hillsborough, New Jersey 08844
United StatesActive - Recruiting
ID Care ( Site 1507)
Hillsborough 5099079, New Jersey 5101760 08844
United StatesSite Not Available
Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Regional Center for Infectious Diseases ( Site 1516)
Greensboro, North Carolina 27401
United StatesActive - Recruiting
Regional Center for Infectious Diseases ( Site 1516)
Greensboro 4469146, North Carolina 4482348 27401
United StatesSite Not Available
The Ohio State University ( Site 1536)
Columbus, Ohio 43210
United StatesActive - Recruiting
The Ohio State University ( Site 1536)
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
University of Pennsylvania Perelman School of Medicine ( Site 1508)
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
University of Pennsylvania Perelman School of Medicine ( Site 1508)
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Saint Hope Foundation, Inc. ( Site 1504)
Bellaire, Texas 77401
United StatesActive - Recruiting
North Texas Infectious Diseases Consultants ( Site 1500)
Dallas, Texas 75246
United StatesActive - Recruiting
Prism Health North Texas, Oak Cliff Health Center ( Site 1514)
Dallas, Texas 75208
United StatesActive - Recruiting
Texas Center for Infectious Disease Associates ( Site 1502)
Fort Worth, Texas 76104
United StatesActive - Recruiting
DCOL Center for Clinical Research ( Site 1511)
Longview, Texas 75605
United StatesActive - Recruiting
Saint Hope Foundation, Inc. ( Site 1504)
Bellaire 4673353, Texas 4736286 77401
United StatesSite Not Available
North Texas Infectious Diseases Consultants ( Site 1500)
Dallas 4684888, Texas 4736286 75246
United StatesSite Not Available
Prism Health North Texas, Oak Cliff Health Center ( Site 1514)
Dallas 4684888, Texas 4736286 75208
United StatesActive - Recruiting
Texas Center for Infectious Disease Associates ( Site 1502)
Fort Worth 4691930, Texas 4736286 76104
United StatesSite Not Available
DCOL Center for Clinical Research ( Site 1511)
Longview 4707814, Texas 4736286 75605
United StatesSite Not Available

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