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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1323-4689 | Registry Identifier | UTN | |
| 2025-522519-40 | Registry Identifier | EU CT | |
| MK-8591B-062 | Other Identifier | MSD |
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Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2: ISL + ULO | Experimental | Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks |
|
| Phase 2: BIC/FTC/TAF | Active Comparator | Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 50/200/25 mg, administered orally once daily (qd) for 96 weeks |
|
| Phase 3: ISL/ULO and Placebo to BIC/FTC/TAF | Experimental | ISL/ULO fixed dose combination (2/200 mg), administered orally qw, and matching placebo to BIC/FTC/TAF administered orally qd for 96 weeks |
|
| Phase 3: BIC/FTC/TAF and Placebo to ISL/ULO | Active Comparator | BIC/FTC/TAF 50/200/25 mg, administered orally qd, and matching placebo to ISL/ULO administered orally qw for 96 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISL | Drug | ISL 2 x 1 mg oral capsules administered qw for 96 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24 | Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA <50 copies/mL will be reported at week 24. | Week 24 |
| Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24 | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Week 24 |
| Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24 | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Week 24 |
| Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <50 copies/mL will be reported at week 48. | Week 48 |
| Phase 3: Percentage of Participants Who Experience an AE at Week 48 | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Week 48 |
| Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <50 copies/mL will be reported at week 48. | Week 48 |
| Phase 2: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruane Clinical Research Group, Inc. ( Site 1513) | Recruiting | Los Angeles | California | 90036 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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Phase 2: no masking Phase 3: Participant, Sponsor, and Investigator are masked
| ULO | Drug | ULO 2 x 100 mg oral tablets administered qw for 96 weeks |
|
|
| BIC/FTC/TAF | Drug | BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks |
|
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| Placebo for BIC/FTC/TAF | Drug | BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks |
|
| Placebo to ISL/ULO | Drug | ISL/ULO-matching placebo oral tablets administered qw for 96 weeks |
|
| ISL/ULO | Drug | ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks |
|
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. |
| Week 48 |
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <50 copies/mL will be reported at week 96. |
| Week 96 |
| Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <200 copies/mL will be reported at week 24. | Week 24 |
| Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <200 copies/mL will be reported at week 48. | Week 48 |
| Phase 2: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <200 copies/mL will be reported at week 96. | Week 96 |
| Phase 2: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 24 | Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 24 weeks. | Baseline (Day 1) and Week 24 |
| Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 48 | Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 48 weeks. | Baseline (Day 1) and Week 48 |
| Phase 2: Mean Change From Baseline in CD4+ T-Cell Count at Week 96 | Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 96 weeks. | Baseline (Day 1) and Week 96 |
| Phase 2: Percentage of Participants Who Experience an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 102 weeks |
| Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 96 weeks |
| Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 24 | Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 24 will be presented. | Week 24 |
| Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48 | Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 48 will be presented. | Week 48 |
| Phase 2: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96 | Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 96 will be presented. | Week 96 |
| Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <50 copies/mL will be reported at week 96. | Week 96 |
| Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <200 copies/mL will be reported at week 48. | Week 48 |
| Phase 3: Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96 | Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA <200 copies/mL will be reported at week 96. | Week 96 |
| Phase 3: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 48 | Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 48 weeks. | Baseline (Day 1) and Week 48 |
| Phase 3: Mean Change From Baseline in Cluster of Differentiation 4-Positive (CD4+) T-Cell Count at Week 96 | Blood samples will be collected to measure CD4+ T-cell count. The mean change from baseline in CD4+ T-cell count will be calculated at 96 weeks. | Baseline (Day 1) and Week 96 |
| Phase 3: Percentage of Participants Who Experience an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 102 weeks |
| Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 96 weeks |
| Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 48 | Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 48 will be presented. | Week 48 |
| Phase 3: Number of Participants With Evidence of Viral Drug Resistance-Associated Substitutions at Week 96 | Participants who meet the definition of clinically significant confirmed viremia (CSCV) or who discontinue study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation, will be assessed for development of viral drug resistance. Among such participants, those with confirmed HIV-1 RNA ≥400 copies/mL will be included in the resistance analyses set. In addition, anyone for whom available genotypic and/or phenotypic data show evidence of resistance, irrespective of viral load, will also be included in the resistance analyses set. The number of participants in each treatment group who have evidence of resistance-associated substitutions at week 96 will be presented. | Week 96 |
| Phase 3: Mean Change From Baseline in Body Weight at Week 48 | Body weight will be collected throughout the study. | Baseline (Day 1) and Week 48 |
| Phase 3: Mean Change From Baseline in Body Weight at Week 96 | Body weight will be collected throughout the study. | Baseline (Day 1) and Week 96 |
| Vivent Health ( Site 1519) | Recruiting | Denver | Colorado | 80246 | United States |
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| Whitman-Walker Institute ( Site 1538) | Recruiting | Washington D.C. | District of Columbia | 20032 | United States |
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| Midway Immunology and Research Center ( Site 1503) | Recruiting | Ft. Pierce | Florida | 34982 | United States |
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| CAN Community Health- Miami Gardens ( Site 1549) | Recruiting | Miami Gardens | Florida | 33055 | United States |
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| Orlando Immunology Center ( Site 1501) | Recruiting | Orlando | Florida | 32803 | United States |
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| CAN Community Health ( Site 1510) | Recruiting | Sarasota | Florida | 34237 | United States |
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| Triple O Research Institute ( Site 1505) | Recruiting | West Palm Beach | Florida | 33407 | United States |
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| Metro Infectious Diseases Consultants L.L.C. ( Site 1509) | Recruiting | Decatur | Georgia | 30033 | United States |
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| Mercer university, Department of internal medicine-Clinical Research ( Site 1512) | Recruiting | Macon | Georgia | 31201 | United States |
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| Rush University Medical Center-Infectious Disease ( Site 1522) | Recruiting | Chicago | Illinois | 60612 | United States |
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| Henry Ford Hospital ( Site 1535) | Recruiting | Detroit | Michigan | 48202 | United States |
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| KC CARE Health Center ( Site 1506) | Recruiting | Kansas City | Missouri | 64111 | United States |
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| ID Care ( Site 1507) | Recruiting | Hillsborough | New Jersey | 08844 | United States |
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| Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533) | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| Regional Center for Infectious Diseases ( Site 1516) | Recruiting | Greensboro | North Carolina | 27401 | United States |
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| The Ohio State University ( Site 1536) | Recruiting | Columbus | Ohio | 43210 | United States |
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| University of Pennsylvania Perelman School of Medicine ( Site 1508) | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Saint Hope Foundation, Inc. ( Site 1504) | Recruiting | Bellaire | Texas | 77401 | United States |
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| Prism Health North Texas, Oak Cliff Health Center ( Site 1514) | Recruiting | Dallas | Texas | 75208 | United States |
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| North Texas Infectious Diseases Consultants ( Site 1500) | Recruiting | Dallas | Texas | 75246 | United States |
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| Texas Center for Infectious Disease Associates ( Site 1502) | Recruiting | Fort Worth | Texas | 76104 | United States |
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| DCOL Center for Clinical Research ( Site 1511) | Recruiting | Longview | Texas | 75605 | United States |
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| Harborview Medical Center ( Site 1526) | Recruiting | Seattle | Washington | 98104 | United States |
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| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102) | Recruiting | Caba | Buenos Aires | C1425AGC | Argentina |
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| Fundación Huesped ( Site 3100) | Recruiting | CABA | Buenos Aires | C1427CEA | Argentina |
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| Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103) | Recruiting | Mar del Plata | Buenos Aires | B7600FZN | Argentina |
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| Fundación IDEAA ( Site 3101) | Recruiting | Buenos Aires | Buenos Aires F.D. | C1405CKC | Argentina |
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| Instituto CAICI SRL ( Site 3106) | Recruiting | Rosario | Santa Fe Province | S2000PBJ | Argentina |
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| Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105) | Recruiting | San Miguel de Tucumán | Tucumán Province | T4000IHE | Argentina |
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| Spectrum Health ( Site 3307) | Recruiting | Vancouver | British Columbia | V6Z 2T1 | Canada |
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| Gestion clinique médicale l'Actuel ( Site 3303) | Recruiting | Montreal | Quebec | H2L 4P9 | Canada |
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| Biomedica Research Group ( Site 4201) | Recruiting | Santiago | Region M. de Santiago | 7500710 | Chile |
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| Clínica Universidad de Los Andes ( Site 4207) | Recruiting | Santiago | Region M. de Santiago | 7620157 | Chile |
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| Espacio Eme ( Site 4202) | Recruiting | Santiago | Region M. de Santiago | 7770086 | Chile |
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| Bordeaux University Hospital - Pellegrin ( Site 3605) | Recruiting | Bordeaux | Gironde | 33000 | France |
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| Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608) | Recruiting | Toulouse | Haute-Garonne | 31059 | France |
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| Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606) | Recruiting | Nantes | Pays de la Loire Region | 44093 | France |
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| HOPITAL DE LA CROIX ROUSSE ( Site 3613) | Recruiting | Lyon | Rhone | 69317 | France |
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| Hôpital Avicenne ( Site 3602) | Recruiting | Bobigny | Île-de-France Region | 93000 | France |
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| Hôpital Saint-Louis ( Site 3600) | Recruiting | Paris | Île-de-France Region | 75010 | France |
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| Hôpital Bichat - Claude-Bernard ( Site 3601) | Recruiting | Paris | Île-de-France Region | 75018 | France |
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| Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801) | Recruiting | Guatemala City | 01009 | Guatemala |
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| MEDI-K ( Site 3803) | Recruiting | Guatemala City | 01009 | Guatemala |
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| CELAN,S.A ( Site 3802) | Recruiting | Guatemala City | 01010 | Guatemala |
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| Morales Vargas Centro de Investigacion, S.C. ( Site 4502) | Recruiting | León | Guanajuato | 37000 | Mexico |
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| Arké SMO S.A de C.V ( Site 4505) | Recruiting | Veracruz | 91910 | Mexico |
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| Josha Research ( Site 4302) | Recruiting | Bloemfontein | Free State | 9301 | South Africa |
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| Wentworth Hospital ( Site 4303) | Recruiting | Durban | KwaZulu-Natal | 4052 | South Africa |
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| Be Part Yoluntu Centre ( Site 4300) | Recruiting | Mbekweni, Paarl | Western Cape | 7646 | South Africa |
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| Hospital Universitario La Paz ( Site 3404) | Recruiting | Madrid | Madrid, Comunidad de | 28029 | Spain |
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| Consorcio Hospital General Universitario de Valencia ( Site 3406) | Recruiting | Valencia | Valenciana, Comunitat | 46014 | Spain |
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| Hospital Universitari Vall d'Hebron ( Site 3402) | Recruiting | Barcelona | 08035 | Spain |
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| HOSPITAL CLÍNIC DE BARCELONA ( Site 3400) | Recruiting | Barcelona | 08036 | Spain |
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| Hospital Universitario 12 de Octubre ( Site 3405) | Recruiting | Madrid | 28041 | Spain |
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| Complejo Hospitalario Virgen De La Victoria ( Site 3409) | Recruiting | Málaga | 29010 | Spain |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D007239 | Infections |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C558823 | islatravir |
| C000723084 | ulonivirine |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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