Clinical Trials

Numerous clinical trials spanning various phases evaluate dapivirine for HIV pre-exposure prophylaxis, prevention, and sexual and reproductive health interventions. Sponsored by public research bodies, non-profit groups, and regional organizations, these studies encompass active, recruiting, completed, and withdrawn statuses. Key evaluations assess the bioavailability, safety, pharmacokinetics, and adherence of topical formulations, including vaginal rings and rectal gels, in healthy and at-risk populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06250504 RECRUITING
HIV Infections
Africa Health Research Institute
 2024-02-27 PHASE3
NCT05041699 COMPLETED
Pharmacokinetics; Safety Issues; Bleeding
International Partnership for Microbicides, Inc.
 2022-06-20 PHASE1
NCT03965923 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2020-01-09 PHASE3
NCT05416021 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2022-08-01 PHASE1
NCT05416021 Active not recruiting
HIV Infections
International Partnership for Microbicides Inc.
 2022-08-01 Phase 1
NCT04140266 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2020-09-24 PHASE3
NCT03593655 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2019-01-14 PHASE2
NCT03467347 COMPLETED
Healthy; Contraception; Contraceptive Usage; Women
International Partnership for Microbicides, Inc.
 2018-07-17 PHASE1
NCT02862171 COMPLETED
HIV Prevention
International Partnership for Microbicides, Inc.
 2016-07-12 PHASE3
NCT03593655 Completed
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2019-01-14 Phase 2
NCT03393468 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2018-05-10 PHASE1
NCT03074786 WITHDRAWN
HIV-1-infection
International Partnership for Microbicides, Inc.
 2017-11 PHASE2
NCT03234400 COMPLETED
HIV-1-infection
International Partnership for Microbicides, Inc.
 2017-12-04 PHASE1
NCT02858037 COMPLETED
Human Immunodeficiency Virus
International Partnership for Microbicides, Inc.
 2016-07-18 PHASE3
NCT03239483 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2017-10-26 PHASE1
NCT03393468 Completed
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2018-05-10 Phase 1
NCT02808949 COMPLETED
Human Immunodeficiency Virus
International Partnership for Microbicides, Inc.
 2015-02 PHASE1
NCT03239483 Completed
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2017-10-26 Phase 1
NCT03044379 WITHDRAWN
HIV 1 Infection
International Partnership for Microbicides, Inc.
 2015-09-29 PHASE1
NCT02855346 COMPLETED
HIV Prevention
International Partnership for Microbicides, Inc.
 2017-05-03 PHASE1
NCT01539226 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2012-03-27
NCT02847286 COMPLETED
HIV- Prevention
International Partnership for Microbicides, Inc.
 2015-09-01 PHASE1
NCT02028338 COMPLETED
Human Immunodeficiency Virus
International Partnership for Microbicides, Inc.
 2014-06-27 PHASE2
NCT02858024 COMPLETED
HIV
International Partnership for Microbicides, Inc.
 2015-01-12 PHASE1
NCT01617096 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2012-07-24 PHASE3
NCT02010593 COMPLETED
Human Immunodeficiency Virus
International Partnership for Microbicides, Inc.
 2013-12 PHASE2
NCT01924091 COMPLETED
Pharmaokinetics
International Partnership for Microbicides, Inc.
 2013-09 PHASE1
NCT01337570 WITHDRAWN
HIV Infections
International Partnership for Microbicides, Inc.
 2011-07 PHASE3
NCT01337583 WITHDRAWN
HIV Infections
International Partnership for Microbicides, Inc.
 2011-07 PHASE3
NCT01952561 COMPLETED
Pharmacokinetics
International Partnership for Microbicides, Inc.
 2013-11 PHASE1
NCT01548560 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2012-08 PHASE1
NCT01731574 COMPLETED
HIV
International Partnership for Microbicides, Inc.
 2012-12 PHASE1
NCT01363037 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2011-11 PHASE1
NCT01277640 COMPLETED
Topical Penile Exposures
International Partnership for Microbicides, Inc.
 2011-03 PHASE1
NCT01242579 WITHDRAWN
HIV Infections
International Partnership for Microbicides, Inc.
 2011-01 PHASE1
NCT01071174 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2010-04 PHASE1; PHASE2
NCT00799058 COMPLETED
HIV-1 Infections
International Partnership for Microbicides, Inc.
 2009-07-06 PHASE1; PHASE2
NCT00917891 COMPLETED
HIV Infections; Acquired Immunodeficiency Syndrome
International Partnership for Microbicides, Inc.
 2009-11 PHASE1; PHASE2
NCT00917904 COMPLETED
HIV Infections; Acquired Immunodeficiency Syndrome; Healthy
International Partnership for Microbicides, Inc.
 2009-07 PHASE1; PHASE2
NCT01144676 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2010-04 PHASE1
NCT02920827 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2009-08 PHASE1
NCT00613249 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2007-11 PHASE1
NCT00700284 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2004-10 PHASE1
NCT00304642 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2005-11 PHASE1
NCT00332995 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2005-07 PHASE1
NCT00304668 WITHDRAWN
HIV Infections
International Partnership for Microbicides, Inc.
 PHASE1; PHASE2
NCT00469768 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2007-05 PHASE1
NCT00309205 COMPLETED
HIV Infections; HIV-1
International Partnership for Microbicides, Inc.
 2005-12 PHASE1; PHASE2
NCT00303576 COMPLETED
HIV Infections
International Partnership for Microbicides, Inc.
 2005-10 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-09)

Check the Dapivirine (TMC120) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dapivirine non-competitively binds to HIV-1 reverse transcriptase with an IC50 of 24 nM, blocking viral RNA-dependent DNA polymerase activity and halting the transcription of viral RNA into proviral DNA. By suppressing viral cDNA synthesis inside target host cells, dapivirine prevents viral integration and replication, rendering it biologically effective for HIV prevention and pre-exposure prophylaxis in clinical settings utilizing topical formulations.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.