33 completed, 3 withdrawn. 36 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 36 | Completed 33, Withdrawn 3 |
| Phase 2 | 2 | Completed 1, Withdrawn 1 |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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| The Role of Vitamin D in Female Reproductive Tract Immunity Vitamin D and Calcium - Vitamin D Deficiency | Phase 1 | Completed | CONRAD | 22 | 2014-08-01 | 2016-01-08 |
| Tenofovir Levels Following Local Application of Tenofovir Reduced-Glycerin 1% Gel Once Daily Application of TFV RG 1% Gel - Vaginal, Once Daily Application of TFV RG 1% gel - Rectal - HIV Prevention | Phase 1 | Completed | CONRAD | 14 | 2014-04-01 | 2021-06-28 |
| In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products Tenofovir 1% gel, Vaginal product - HIV Prevention | Phase 1 | Completed | CONRAD | 101 | 2013-12-01 | 2015-05-22 |
| A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04 1% vaginally applied tenofovir gel, Tenofovir film- 10mg, Tenofovir Film-40 mg - HIV | Phase 1 | Completed | CONRAD | 78 | 2013-11-01 | 2016-07-27 |
| Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity TFV 1% gel, Estradiol vaginal cream - HIV Prevention | Phase 1 | Completed | CONRAD | 40 | 2013-09-01 | 2015-04-10 |
| A Study to Compare Three Different Formulations of Tenofovir 1% Gel When Administered Rectally Rectal formulation (RF) of tenofovir 1% gel, Vaginal formulations (original VF and reduced vaginal glycerin formulation RGVF) of tenofovir 1% gel, Universal HEC Placebo Gel Formulation - HIV Prevention | Phase 1 | Completed | Ian McGowan | 13 | 2013-03-01 | 2013-11-07 |
| An Exploratory Rectal Safety Study of Three Tenofovir Gel Formulations Rectal formulation (RF) of tenofovir 1% gel, Vaginal formulation (VF) of tenofovir 1% gel, Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel - HIV Prevention | Phase 1 | Completed | Ian McGowan | 9 | 2013-03-01 | 2014-05-08 |
| Safety, Pharmacokinetics, Pharmacodynamics, and Disintegration Time of Vaginal Tablets Containing Tenofovir and/or Emtricitabine Tenofovir (TFV) Alone Vaginal Tablet, Emtricitabine (FTC) Alone Vaginal Tablet, TFV and FTC Combined Vaginal Tablet - HIV | Phase 1 | Completed | CONRAD | 48 | 2013-02-01 | 2015-04-03 |
Showing 20 of 36. Sign in to see all of them.
HIV Infections (8) · Acquired Immunodeficiency Syndrome (2) · Contraception Behavior (1) · Vitamin D Deficiency (1)
Tenofovir (12) · Gels (7) · Vaginal Creams, Foams, and Jellies (4) · Emtricitabine (3) · Medroxyprogesterone Acetate (2) · UC-781 (2) · Adenine (1) · Calcium (1) · Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination (1) · Lubricants (1) · Menstrual Hygiene Products (1) · N,N-dimethyl-4-anisidine (1) · Nonoxynol (1) · Racivir (1) · Seeds (1)
United States (34) · Dominican Republic (7) · South Africa (2) · Botswana (1) · Kenya (1) · Puerto Rico (1) · Thailand (1)
Jill Schwartz, MD (5) · Jill Schwartz, M.D. (2) · Alex Carballo-Dieguez, PhD (1) · Andrea R Thurman, M.D. (1) · Andrea Thurman, M.D. (1) · Beatrice A. Chen, MD, MPH (1) · Betsy Herold, MD (1) · Cassie Grimsley Ackerley, MD, MSc (1) · Chitlada Utaipiboon, MD (1) · Chris Mauck, MD (1) · Christine K Mauck, MD, MPH (1) · Christine K. Mauck, M.D. (1) · Christine Mauck (1) · Craig Hendrix, MD (1) · Dawn K Smith, MD, MPH (1)
PMID 22900504, PMID 34878438, PMID 41869811, PMID 16940442, PMID 17303493, PMID 17494097, PMID 18692615, PMID 21969851, PMID 22039430, PMID 22943559, PMID 23573238, PMID 23842718, PMID 25350119, PMID 25350130, PMID 25647729, PMID 25942472, PMID 26227279, PMID 26508513, PMID 27362788, PMID 29953547, PMID 30101439, PMID 30222141, PMID 31107913, PMID 31442441, PMID 34041459, PMID 35350436, PMID 35363574, PMID 36215267, PMID 37153145, PMID 38655842, PMID 40354181, PMID 40447283
U19AI082637 (2), 3UM1AI068633 (1), 5UM1AI068633 (1), U01AI068633 (1), U19AI051661 (1), U19AI060614 (1), U19AI082639 (1), U19AI113127 (1), U54HD042454 (1), UM1AI068615 (1)