54 completed, 3 withdrawn, 2 unknown, 1 terminated. 36 Phase 1, 12 Phase 2, 6 Not applicable, 4 Phase 3, 3 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 36 | Completed 33, Withdrawn 3 |
| Phase 2 | 12 | Completed 9, Unknown 2, Withdrawn 1 |
| Not applicable | 6 | Completed 6 |
| Phase 3 | 4 | Completed 3, Terminated 1 |
| Phase 4 | 3 | Completed 3 |
| Early Phase 1 | 1 | Completed 1 |
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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 |
|---|---|---|---|---|---|---|
| Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study TAF/EVG rectal insert, Matching placebo rectal insert - Safety Issues | Phase 1 | Completed | Eastern Virginia Medical School | 21 | 2024-01-16 | 2025-07-25 |
| Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert TAF/EVG vaginal insert, Matching Placebo vaginal insert - Safety Issues | Phase 1 | Completed | Eastern Virginia Medical School | 68 | 2023-11-08 | 2025-09-02 |
| Effectiveness of Smartphone Application for Adherence Support (Vuka+) Vuka+ application - Adherence, Medication, Smartphone Application | Not applicable | Completed | Eastern Virginia Medical School | 330 | 2022-12-15 | 2025-03-26 |
| Project Engage: Oral PrEP Acceptability emtricitabine/tenofovir alafenamide, Emtricitabine / Tenofovir Disoproxil Oral Tablet - Acceptability of Health Care, Adherence, Medication | Phase 2 | Completed | Eastern Virginia Medical School | 330 | 2022-06-21 | 2024-07-29 |
| Evaluating Distribution of a Tenofovir Douche With Tap Water Douching and Simulated Receptive Anal Intercourse Tenofovir Douche - HIV/AIDS, HIV Prevention | Phase 1 | Completed | Johns Hopkins University | 6 | 2021-06-01 | 2023-01-17 |
| Impact of Contraceptives on Cervico-Vaginal Mucosa Copper IUD, Etonogestrel implant, Levonorgestrel IUS - Mucosal Inflammation, Contraceptive; Complications, Intrauterine | Phase 4 | Completed | Eastern Virginia Medical School | 112 | 2021-03-01 | 2023-08-25 |
| A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48), Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48), Vaccine Group C: Saline placebo (weeks 0,4,24,48) - HIV Infections | Phase 2 | Completed | MRC/UVRI and LSHTM Uganda Research Unit | 1512 | 2020-12-15 | 2025-01-22 |
| Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally TAF/EVG Insert - HIV Infections | Phase 1 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 23 | 2019-12-11 | 2023-12-22 |
| Tenofovir/Levonorgestrel Intravaginal Ring and Tenofovir Intravaginal Ring TFV/LNG IVR, TFV IVR, Placebo IVR - HIV, Contraception | Phase 2 | Unknown | CONRAD | 50 | 2018-12-12 | 2020-01-14 |
| Safety, PK, and PD Study of a Vaginal Insert Containing TAF and EVG TAF/EVG Vaginal Insert - Hiv, HSV | Phase 1 | Completed | CONRAD | 16 | 2018-12-10 | 2019-07-16 |
| Safety, PK, and PD Study of IVRs Releasing TFV and LNG TFV/LNG IVR, Placebo - Anti-Infective Agents, Anti-Retroviral Agents | Phase 1 | Completed | CONRAD | 66 | 2017-09-28 | 2019-07-23 |
| PK and PD Study of Oral F/TAF for HIV Prevention Emtricitabine, Tenofovir alafenamide, Tenofovir disoproxil - HIV | Phase 1 | Completed | CONRAD | 73 | 2016-10-06 | 2018-02-19 |
| The Quatro Study: Acceptability Study of (Placebo) Vaginal Delivery Forms for Preventing HIV and Unintended Pregnancy HEC Placebo Gel, Placebo Vaginal Insert, Placebo Vaginal Film - HIV, Contraception | Not applicable | Completed | CONRAD | 422 | 2016-06-06 | 2018-05-18 |
| Exploratory Pharmacodynamic Study of Tenofovir-Based Products Tenofovir intravaginal ring, Truvada - HIV | Phase 1 | Completed | CONRAD | 25 | 2016-04-01 | 2016-09-02 |
| Development of Adherence Biomarkers for Multiple Microbicide and Multipurpose Prevention Technology (MPT) Dosage Forms HEC Placebo gel, Placebo Intravaginal Ring, Placebo Vaginal Film - HIV | Phase 1 | Completed | CONRAD | 50 | 2015-10-01 | 2016-09-02 |
| Assessing the Disintegration, Safety, and Acceptability of Placebo Vaginal Inserts for the Delivery of Vaginal Products Placebo Vaginal Insert - Vaginal Diseases | Not applicable | Completed | CONRAD | 49 | 2015-08-01 | 2016-06-02 |
| A Safety Study Of The Caya® Diaphragm Used With ContraGel® ContraGel, HEC Universal Placebo gel - Contraception | Phase 1 | Completed | CONRAD | 23 | 2015-07-01 | 2016-05-27 |
| Postcoital Testing Study of the SILCS Diaphragm Used With 3% N-9 Gel, ContraGel, or No Gel SILCS diaphragm used with ContraGel, SILCS diaphragm used with 3% Nonoxynol-9, SILCS diaphragm - Contraception | Phase 1 | Completed | CONRAD | 27 | 2014-12-01 | 2016-08-01 |
| Comparison of Tenofovir Vaginal Gel and Film Formulations Tenofovir Gel, Tenofovir Film - Healthy, HIV | Early Phase 1 | Completed | CONRAD | 10 | 2014-11-01 | 2016-01-28 |
| Phase I One-month Safety, PK, PD, and Acceptability Study of IVR Releasing TFV and LNG or TFV Alone TFV IVR, TFV/LNG IVR, Placebo IVR - HIV, Contraception | Phase 1 | Completed | CONRAD | 86 | 2014-10-01 | 2016-01-11 |
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HIV Infections (11) · Acquired Immunodeficiency Syndrome (2) · Medication Adherence (2) · Vaginitis (2) · Contraception Behavior (1) · Health Education (1) · Mucositis (1) · Patient Acceptance of Health Care (1) · Rupture (1) · Sexually Transmitted Diseases (1) · Trachoma (1) · Vaginal Discharge (1) · Vaginal Diseases (1) · Vaginosis, Bacterial (1) · Vitamin D Deficiency (1)
Tenofovir (18) · Gels (8) · Vaginal Creams, Foams, and Jellies (5) · Emtricitabine (3) · Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination (3) · Medroxyprogesterone Acetate (2) · Nonoxynol (2) · UC-781 (2) · emtricitabine tenofovir alafenamide (2) · Adenine (1) · Calcium (1) · Imiquimod (1) · Intrauterine Devices, Copper (1) · Levonorgestrel (1) · Lubricants (1)
United States (47) · South Africa (10) · Dominican Republic (8) · Kenya (3) · Puerto Rico (2) · Thailand (2) · Uganda (2) · Zimbabwe (2) · Benin (1) · Botswana (1) · Chile (1) · India (1) · Peru (1)
Jill Schwartz, MD (6) · Andrea R Thurman, MD (2) · Andrea Thurman, M.D. (2) · Homaira Hanif, PhD (2) · Jill Schwartz, M.D. (2) · Quarraisha Abdool Karim, PhD (2) · Alex Carballo-Dieguez, PhD (1) · Alfred Poindexter, MD (1) · Andrea R Thurman, M.D. (1) · Andrea Thurman (1) · Anna Wald, MD, MPH (1) · Beatrice A. Chen, MD, MPH (1) · Betsy Herold, MD (1) · Cassie Grimsley Ackerley, MD, MSc (1) · Chitlada Utaipiboon, MD (1)
PMID 41869811, PMID 22900504, PMID 34878438, PMID 16940442, PMID 17303493, PMID 17494097, PMID 18669425, PMID 18692615, PMID 20643915, PMID 21048963, PMID 21385354, PMID 21969851, PMID 22039430, PMID 22781225, PMID 22943559, PMID 23472071, PMID 23481666, PMID 23573238, PMID 23657072, PMID 23842718, PMID 24909636, PMID 25350119, PMID 25350130, PMID 25527071, PMID 25647729, PMID 25751199, PMID 25942472, PMID 26044291, PMID 26227279, PMID 26244306, PMID 26265463, PMID 26508513, PMID 27259675, PMID 27362788, PMID 27986684, PMID 28348164, PMID 28750059, PMID 28825142, PMID 29025127, PMID 29076032, PMID 29119473, PMID 29501908, PMID 29953547, PMID 30101439, PMID 30222141, PMID 30318905, PMID 30336747, PMID 30507409, PMID 31107913, PMID 31299013
5UM1AI068633 (2), U19AI082637 (2), U19AI082639 (2), 3UM1AI068633 (1), U01AI068633 (1), U19AI051661 (1), U19AI060614 (1), U19AI113127 (1), U54HD042454 (1), UM1AI068615 (1)