124 completed, 15 terminated, 10 unknown, 3 withdrawn. 43 Phase 1, 38 Phase 4, 34 Phase 3, 28 Phase 2, 4 Not applicable.
Follow Darunavir: new trials by email Literature Review of Darunavir trials Research Report on Darunavir
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 |
|---|---|---|---|---|---|---|
| An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa Dolutegravir (DTG), Abacavir (ABC), Lamivudine (3TC) - HIV Infection | Phase 3 | Not yet recruiting | University College, London | 800 | 2026-11-01 | 2026-08-28 |
| Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults. Dolutegravir (DTG), Darunavir/Cobicistat (FDC) - HIV, Insomnia | Phase 4 | Unknown | Instituto Mexicano del Seguro Social | 140 | 2025-06-19 | 2025-06-26 |
| Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV Gammora® - HIV Seropositivity | Phase 2 | Active not recruiting | Federal University of São Paulo | 40 | 2025-01-01 | 2026-06-01 |
| Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain Biktarvy, Symtuza - HIV Infections, Obesity | Phase 4 | Unknown | East Carolina University | 30 | 2023-03-14 | 2023-11-14 |
| A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants DRV/COBI FDC, COBI, DRV - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 32 | 2022-06-07 | 2022-10-26 |
| Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART) Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC) - HIV-1-infection | Phase 4 | Completed | The Crofoot Research Center, Inc. | 75 | 2021-09-01 | 2024-04-26 |
| Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum Bictegravir (BIC), Tenofovir alafenamide (TAF), Long-acting injectable formulation of cabotegravir (CAB LA) - HIV, Tuberculosis | Terminated | National Institute of Allergy and Infectious Diseases (NIAID) | 205 | 2021-09-01 | 2026-08-26 | |
| Inflammation and Co-Infections in D²EFT NRTIs, Darunavir, Ritonavir - HIV-infection/Aids, Human Herpesvirus 4 Infections | Phase 4 | Withdrawn | Kirby Institute | 2021-02-01 | 2020-11-10 | |
| A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions Darunavir, Cobicistat, Darunavir/Cobicistat FDC - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 22 | 2021-01-26 | 2025-02-03 |
| A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC, Darunavir, Emtricitabine/Tenofovir Alafenamide - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 37 | 2021-01-05 | 2025-02-03 |
| Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR) GSK3640254, Darunavir/Ritonavir (DRV/RTV), Etravirine (ETR) - HIV Infections | Phase 1 | Completed | ViiV Healthcare | 54 | 2020-10-28 | 2024-08-29 |
| Contribution of Dolutegravir to Obesity and Cardiovascular Disease Dolutegravir 50 MG, Antiretroviral/Anti HIV - HIV-1-infection, Antiviral Drug Adverse Reaction | Phase 4 | Completed | Augusta University | 10 | 2020-09-17 | 2023-07-27 |
| A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC, Darunavir, Emtricitabine/Tenofovir Alafenamide - Healthy | Phase 1 | Terminated | Janssen Pharmaceutica N.V., Belgium | 16 | 2020-01-23 | 2020-07-07 |
| A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants Dabigatran Etexilate, DRV/COBI, Ritonavir - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 28 | 2019-12-18 | 2025-02-03 |
| Body Composition Sub-study of the D2EFT Trial Darunavir (DRV) 800 milligram (MG) Oral Tablet, Ritonavir 100 MG Oral Tablet, N(t)RTIs - HIV Infections | Phase 4 | Completed | Kirby Institute | 155 | 2019-12-05 | 2025-01-09 |
| Nucleosides And Darunavir/Dolutegravir In Africa Darunavir, Ritonavir, Dolutegravir - Human Immunodeficiency Virus | Phase 3 | Unknown | Makerere University | 465 | 2019-07-30 | 2020-07-30 |
| Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson&Jonson", Russia) GP30101, Prezista® - Bioequivalence | Not applicable | Completed | Geropharm | 44 | 2019-06-06 | 2024-07-22 |
| HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) Darunavir, Ritonavir, Dolutegravir - Amyotrophic Lateral Sclerosis | Phase 1 | Completed | National Institute of Neurological Disorders and Stroke (NINDS) | 122 | 2019-04-01 | 2024-01-09 |
| Raltegravir One Thousand Two Hundred vs Darunavir-cb in Immnunosupressed Patients: ROTDIP Study Experimental: RAL QD, Active comparator: DRV/cb - HIV Infections | Phase 4 | Unknown | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | 75 | 2019-04-01 | 2019-02-15 |
| Evaluation of Third-line cART Regimen in Cambodia (3DICAM) Dolutegravir + Darunavir/ritonavir + optimized NRTI - HIV/AIDS | Phase 2 | Unknown | ANRS, Emerging Infectious Diseases | 54 | 2018-10-04 | 2021-08-26 |
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HIV Infections (62) · Acquired Immunodeficiency Syndrome (44) · Infections (5) · Hepatitis C (3) · AIDS Dementia Complex (2) · Hyperlipidemias (2) · Virus Diseases (2) · Amyotrophic Lateral Sclerosis (1) · Anxiety Disorders (1) · Asthma (1) · Body Weight Changes (1) · Cardiovascular Abnormalities (1) · Cardiovascular Diseases (1) · Cognition Disorders (1) · Cognitive Dysfunction (1)
Tibotec Pharmaceuticals, Ireland (17) · ViiV Healthcare (7) · ANRS, Emerging Infectious Diseases (6) · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (5) · Gilead Sciences (5) · Janssen Sciences Ireland UC (5) · Kirby Institute (5) · St Stephens Aids Trust (5) · Tibotec, Inc (5) · Janssen Research & Development, LLC (4) · National Institute of Allergy and Infectious Diseases (NIAID) (4) · Boehringer Ingelheim (3) · Germans Trias i Pujol Hospital (3) · Janssen-Cilag S.p.A. (3) · Bristol-Myers Squibb (2)
United States (55) · Spain (21) · United Kingdom (21) · France (20) · Puerto Rico (19) · Belgium (17) · Germany (17) · Thailand (14) · South Africa (13) · Argentina (12) · Brazil (11) · Canada (11) · Austria (8) · Italy (8) · Australia (7)
Christine Katlama, MD (2) · Mark Mirochnick, MD (2)
PMID 25904376, PMID 26797215, PMID 30412360, PMID 35179037, PMID 35315687, PMID 16470119, PMID 16988514, PMID 17416261, PMID 17621237, PMID 18366444, PMID 18795962, PMID 18989231, PMID 19724191, PMID 20002783, PMID 20010070, PMID 20386077, PMID 20632458, PMID 20710052, PMID 20802297, PMID 20855799, PMID 21283017, PMID 21470045, PMID 21857490, PMID 22007990, PMID 22083071, PMID 22129166, PMID 22288567, PMID 22848481, PMID 23092052, PMID 23196938, PMID 23305215, PMID 23364475, PMID 23392467, PMID 23441978, PMID 23494984, PMID 23558157, PMID 23591634, PMID 23797691, PMID 23824675, PMID 23851911, PMID 24352352, PMID 24396625, PMID 24417772, PMID 24434370, PMID 24698485, PMID 24825411, PMID 25103176, PMID 25109510, PMID 25162818, PMID 25170938
2014 (5), U01AI068636 (5), 2009 (4), 2015 (3), 2008 (2), 2019 (2), 2004 (1), 2017 (1), R01AI120765 (1), R01MH058076 (1), U01AI068632 (1)