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Vaginal TFV Gel
Tenofovir (TFV) gel applied vaginally blocks HIV reverse transcriptase to prevent sexual transmission of HIV.
Tenofovir (TFV) gel applied vaginally blocks HIV reverse transcriptase to prevent sexual transmission of HIV. Used for HIV prevention in women via vaginal application (CAPRISA 004 trial demonstrated efficacy).
At a glance
| Generic name | Vaginal TFV Gel |
|---|---|
| Also known as | Tenofovir 1% Vaginal Gel |
| Sponsor | University of Washington |
| Drug class | Nucleotide reverse transcriptase inhibitor (microbicide) |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / HIV Prevention |
| Phase | FDA-approved |
Mechanism of action
Tenofovir is a nucleotide reverse transcriptase inhibitor that, when formulated as a vaginal microbicide gel, creates a protective barrier against HIV infection at the site of potential viral exposure. The drug is absorbed locally and systemically to inhibit HIV replication if viral exposure occurs during sexual intercourse. This approach provides women with a user-controlled prevention option independent of partner cooperation.
Approved indications
- HIV prevention in women via vaginal application (CAPRISA 004 trial demonstrated efficacy)
Common side effects
- Vaginal irritation or discomfort
- Genital erythema
- Vulvovaginal candidiasis
- Abnormal vaginal discharge
Key clinical trials
- Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding (PHASE4)
- Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women (PHASE1)
- Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women (PHASE2)
- Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women (PHASE2)
- Tenofovir Levels Following Local Application of Tenofovir Reduced-Glycerin 1% Gel (PHASE1)
- In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products (PHASE1)
- Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females (PHASE1)
- Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vaginal TFV Gel CI brief — competitive landscape report
- Vaginal TFV Gel updates RSS · CI watch RSS
- University of Washington portfolio CI