168 completed, 16 terminated, 12 unknown, 9 active not recruiting. 76 Phase 2, 49 Phase 3, 43 Phase 1, 22 Phase 4, 16 Not applicable.
Follow HIV-1 Infection: new trials by email Literature Review of HIV-1 Infection trials Research Report on HIV-1 Infection
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV BIC/LEN FDC, Lenacapavir, SBR - HIV-1 Infection | Phase 4 | Not yet recruiting | Gilead Sciences | 400 | 2026-11-01 | 2026-11-02 |
| Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels B/F/TAF, GS-3242, Lenacapavir - HIV-1 Infection | Phase 2 | Recruiting | Gilead Sciences | 125 | 2026-10-01 | 2026-10-23 |
| Intestinal Tissue-Resident Memory T Cells and HIV-1 Persistence During Antiretroviral Therapy Colonic Mucosal Biopsies - HIV-1 Infection, HIV Reservoir | Not applicable | Not yet recruiting | ANRS, Emerging Infectious Diseases | 30 | 2026-08-01 | 2026-06-18 |
| Qiling Yiqi Tablets Plus Antiretroviral Therapy for HIV Immune Non-responders With Lung-Spleen Qi Deficiency Qiling Yiqi Tablets plus ART, Antiretroviral Therapy (ART) - HIV-1 Infection, Acquired Immunodeficiency Syndrome | Not applicable | Not yet recruiting | Beijing University of Chinese Medicine | 240 | 2026-08-01 | 2026-07-13 |
| Fuyang Jiedu Granules Plus Antiretroviral Therapy for HIV Immune Non-Responders With Spleen-Kidney Yang Deficiency Fuyang Jiedu Granules, Antiretroviral Therapy (ART) - HIV-1 Infection, Acquired Immunodeficiency Syndrome | Not applicable | Not yet recruiting | Beijing University of Chinese Medicine | 240 | 2026-08-01 | 2026-07-13 |
| A Phase Ⅱa Clinical Study of CL-197 Capsules CL-197 capsules - HIV-1 Infection | Phase 2 | Recruiting | Henan Genuine Biotech Co., Ltd. | 24 | 2025-11-29 | 2026-01-06 |
| A Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy in Patients With Multi-Drug Resistant HIV-1 Infection UB-421 - Multi-Drug Resistant Hiv-1 Infection, HIV-1 Infection | Phase 2 | Withdrawn | National Institute of Allergy and Infectious Diseases (NIAID) | 2025-07-10 | 2025-07-11 | |
| Pomalidomide as an Immune-enhancing Agent for the Control of HIV Pomalidomide 2 mg, Placebo, Aspirin 75 mg - HIV-1 Infection | Phase 1 / Phase 2 | Active not recruiting | University of Aarhus | 32 | 2025-05-13 | 2026-05-07 |
| To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults UB-421, current standard HAART treatment - HIV-1 Infection | Phase 3 | Withdrawn | United BioPharma | 2025-04-01 | 2023-04-25 | |
| Clinical Research on the Use of Immune Checkpoint Inhibitors Combined With Chidamide for the Functional Cure of AIDS PD-1 inhibitor, Sidarbenamide, Saline (NaCl 0,9 %) (placebo) - HIV-1 Infection | Not applicable | Not yet recruiting | Jun Chen, MD | 33 | 2025-03-22 | 2025-03-30 |
| Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI Integrase inhibitor, Doravirine + tenofovir DF + lamivudine - HIV, HIV Associate Weight Loss | Phase 4 | Unknown | Instituto Mexicano del Seguro Social | 108 | 2024-08-14 | 2024-09-19 |
| UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection UB-421, Antiretroviral (ARV) - HIV-1 Infection | Phase 3 | Unknown | United BioPharma | 50 | 2023-12-01 | 2023-04-24 |
| UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients UB-421, Optimized background therapy (OBT) - HIV-1 Infection | Phase 2 | Unknown | United BioPharma | 10 | 2023-12-01 | 2023-04-24 |
| Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration, Out of Hospital long-acting Vocabria (cabotegravir) 600 mg and long-acting Rekambys (rilpivirine) 900 mg administration - HIV-1 Infection | Phase 4 | Completed | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | 103 | 2023-09-26 | 2025-07-14 |
| A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection Teropavimab, Zinlirvimab, Lenacapavir Tablet - HIV-1 Infection | Phase 2 | Active not recruiting | Gilead Sciences | 83 | 2023-05-15 | 2026-04-27 |
| DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053) DOR/ISL, BIC/FTC/TAF, Placebo to DOR/ISL - HIV-1 Infection | Phase 3 | Active not recruiting | Merck Sharp & Dohme LLC | 537 | 2023-03-08 | 2026-10-05 |
| A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051) ART, DOR/ISL - HIV-1 Infection | Phase 3 | Active not recruiting | Merck Sharp & Dohme LLC | 553 | 2023-02-20 | 2025-11-21 |
| A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052) DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF - HIV-1 Infection | Phase 3 | Active not recruiting | Merck Sharp & Dohme LLC | 514 | 2023-02-17 | 2025-11-18 |
| A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs UB-421, chidamide - HIV-1 Infection | Phase 2 | Completed | United BioPharma | 11 | 2021-12-02 | 2023-02-15 |
| Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV ISL, LEN, B/F/TAF - HIV-1 Infection | Phase 2 | Active not recruiting | Gilead Sciences | 142 | 2021-10-05 | 2026-02-04 |
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HIV Infections (13) · Acquired Immunodeficiency Syndrome (11) · Infections (8) · Hepatitis C (3) · Tuberculosis (3) · Cardiovascular Diseases (2) · Inflammation (2) · Alzheimer Disease (1) · Anxiety Disorders (1) · Body Weight Changes (1) · Cognition Disorders (1) · Cognitive Dysfunction (1) · Depression (1) · Fatigue Syndrome, Chronic (1) · Fibromyalgia (1)
Infections (30) · Virus Diseases (30) · RNA Virus Infections (28) · Blood-Borne Infections (27) · Communicable Diseases (27) · Urogenital Diseases (26) · Immune System Diseases (25) · Genital Diseases (24) · Immunologic Deficiency Syndromes (24) · Lentivirus Infections (24) · Retroviridae Infections (24) · Sexually Transmitted Diseases (24) · Sexually Transmitted Diseases, Viral (24) · HIV Infections (11) · Slow Virus Diseases (11)
Lamivudine (19) · Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination (17) · Ritonavir (16) · bictegravir, emtricitabine, tenofovir alafenamide, drug combination (16) · Raltegravir Potassium (13) · dolutegravir (13) · Tenofovir (11) · efavirenz (11) · Darunavir (10) · doravirine (10) · Atazanavir Sulfate (9) · Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination (8) · Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination (8) · UB-421 (8) · islatravir (8)
Gilead Sciences (34) · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (30) · Merck Sharp & Dohme LLC (25) · ANRS, Emerging Infectious Diseases (18) · United BioPharma (8) · Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia (7) · University of North Carolina, Chapel Hill (5) · Bionor Immuno AS (3) · Rockefeller University (3) · AbbVie (2) · Beijing University of Chinese Medicine (2) · Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida (2) · Fundación Huésped (2) · GlaxoSmithKline (2) · Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba (2)
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Christine Katlama, MD (3) · Beatriz Grinsztejn, MD, PhD (2) · Cindy L Gay, MD, MPH (2) · David Margolis, MD (2) · Dominique Costagliola, PhD (2) · Marina Caskey, MD (2) · Meagan O'Brien, MD (2) · Netanya Sandler, MD (2)
PMID 29956087, PMID 36912172, PMID 30101539, PMID 30803969, PMID 30932951, PMID 31068270, PMID 31430369, PMID 32504574, PMID 33880558, PMID 37200995, PMID 38349226, PMID 39229805, PMID 40197415, PMID 42213454, PMID 18383194, PMID 19581631, PMID 20133266, PMID 20559034, PMID 20710052, PMID 21148530, PMID 21317794, PMID 21324375, PMID 21486960, PMID 21811136, PMID 22190606, PMID 22837004, PMID 23274932, PMID 23797691, PMID 23830355, PMID 23875707, PMID 23924590, PMID 24446523, PMID 24620025, PMID 24864123, PMID 24907403, PMID 25028911, PMID 25214516, PMID 25454870, PMID 25624326, PMID 25979307, PMID 26060295, PMID 26075752, PMID 26258571, PMID 26271944, PMID 26461452, PMID 26636929, PMID 26684819, PMID 26702094, PMID 26762988, PMID 27036991
U01AI068636 (17), 2015 (12), UM1AI068636 (10), 2014 (9), 2017 (5), 2019 (4), 2UM1AI068636 (3), 2008 (2), 2009 (2), 2016 (2), U01AI117844 (2), 5UM1AI068634 (1), R01AG054366 (1), R01AI066992 (1), R01HL125042 (1)