9 completed, 2 unknown, 1 withdrawn. 12 Phase 2, 2 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 9, Unknown 2, Withdrawn 1 |
| Phase 1 | 2 | Completed 1, Withdrawn 1 |
| Phase 3 | 2 | Completed 2 |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet), Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel), Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel) - HIV | Phase 2 | Completed | CONRAD | 195 | 2013-09-25 | 2021-06-24 |
| Implementation Effectiveness and Safety of Tenofovir Gel Provision Through Family Planning Services 1% tenofovir gel - HIV | Phase 2 / Phase 3 | Completed | Centre for the AIDS Programme of Research in South Africa | 372 | 2012-10-01 | 2019-11-26 |
| Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation Imiquimod, Placebo, Nonoxynol-9 - Vaginal Inflammation, Vaginal Infections | Phase 2 | Completed | CONRAD | 20 | 2012-05-01 | 2015-03-31 |
| Study of a COX-2 Inhibitor for Prevention of Ovulation Meloxicam - Rupture; Graafian Follicle | Phase 2 | Unknown | Instituto Chileno de Medicina Reproductiva | 56 | 2011-01-01 | 2011-05-03 |
| Contraceptive Effectiveness and Safety of the SILCS Diaphragm SILCS Diaphragm, Nonoxynol-9 Gel, Buffer Gel - Contraception | Phase 2 / Phase 3 | Completed | CONRAD | 450 | 2008-01-01 | 2018-03-16 |
| Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV Tenofovir gel, Placebo (Universal HEC placebo) - HIV Infections | Phase 2 | Completed | Centre for the AIDS Programme of Research in South Africa | 889 | 2007-05-01 | 2016-02-01 |
| Contraceptive Effectiveness Trial of Cellulose Sulfate Gel Cellulose sulfate vaginal gel - Contraception | Phase 2 | Completed | CONRAD | 200 | 2005-01-01 | 2005-11-18 |
| Male Hormonal Contraceptive Development-ACY-5 Acyline, Testosterone Gel, Depo-Medroxyprogesterone - Contraception | Phase 1 / Phase 2 | Completed | University of Washington | 43 | 2004-05-01 | 2008-09-19 |
| Paper Applicator Acceptability Study TFV 1% gel - HIV Prevention | Phase 1 / Phase 2 | Withdrawn | CONRAD | 2015-04-10 |
HIV Infections (2) · Medication Adherence (1) · Patient Acceptance of Health Care (1) · Rupture (1) · Vaginitis (1)
Tenofovir (3) · Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination (2) · Gels (2) · emtricitabine tenofovir alafenamide (2) · Imiquimod (1) · Medroxyprogesterone Acetate (1) · Meloxicam (1) · N,N-dimethyl-4-anisidine (1) · Nonoxynol (1) · Testosterone (1) · acyline (1) · hydroxyethylcellulose (1)
South Africa (5) · United States (5) · Chile (1) · Kenya (1) · Peru (1) · Puerto Rico (1) · Thailand (1) · Uganda (1) · Zimbabwe (1)
Quarraisha Abdool Karim, PhD (2) · Alfred Poindexter, MD (1) · Andrea R Thurman, MD (1) · Christine K Mauck, MD (1) · David Archer, MD (1) · Gustavo Doncel, MD,PhD (1) · Homaira Hanif, PhD (1) · Javier R. Lama, MD, MPH (1) · Jonathan Weber, PhD (1) · Kurt Barnhart, MD (1) · Leila E Mansoor, Ph.D. (1) · Lynn Bradley, M.Sc. (1) · Mitch M Creinin, MD (1) · Nelly R. Mugo, MBChB (1)
PMID 16940442, PMID 17303493, PMID 17494097, PMID 20643915, PMID 21385354, PMID 22781225, PMID 23472071, PMID 23481666, PMID 24909636, PMID 25527071, PMID 25751199, PMID 26244306, PMID 27986684, PMID 28348164, PMID 28750059, PMID 28825142, PMID 29025127, PMID 29076032, PMID 29119473, PMID 29501908, PMID 30318905, PMID 30336747, PMID 31299013, PMID 34541872, PMID 35835755, PMID 36162740, PMID 36357877, PMID 36504254, PMID 37383290, PMID 40268488, PMID 41259346, PMID 41650395, PMID 41869811, PMID 42141483, PMID 42410635
5UM1AI068633 (1), U54HD042454 (1)