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Antiviral

1 for Human Immunodeficiency Virus Infection

Phase 1
Waitlist Available
Led By Betsy Herold, MD
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at days 3, 7, 14, and 21
Awards & highlights

Study Summary

Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease-causing agents. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). The purpose of this study is to assess whether there is a measurable response to daily applications of a topical microbicide, 1% tenofovir gel, in women at low risk for HIV infection.

Eligible Conditions
  • Human Immunodeficiency Virus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at days 3, 7, 14, and 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and at days 3, 7, 14, and 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in cytokines, chemokines, and other mediators of innate immunity through examination of cervicovaginal secretions
Secondary outcome measures
Changes in antimicrobial activity of cervicovaginal secretions

Side effects data

From 2010 Phase 2 trial • 168 Patients • NCT00592124
15%
Hypophosphataemia
14%
Nausea
10%
Vulvovaginal pruritus
8%
Headache
7%
Upper respiratory tract infection
6%
Vaginal discharge
6%
Diarrhoea
5%
Haemoglobin decreased
4%
Vomiting
3%
Blood phosphorus decreased
2%
Vulvovaginal candidiasis
1%
Drug eruption
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vaginal and Oral Tenofovir
Oral Tenofovir
Vaginal Tenofovir

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Application of 1% tenofovir gel for 14 consecutive days between menses
Group II: 2Placebo Group1 Intervention
Application of 1% tenofovir placebo gel for 14 consecutive days between menses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir gel
2011
Completed Phase 3
~3200

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,439 Total Patients Enrolled
Betsy Herold, MDPrincipal InvestigatorAlbert Einstein College of Medicine
1 Previous Clinical Trials
31 Total Patients Enrolled
Marla Keller, MDPrincipal InvestigatorAlbert Einstein College of Medicine
1 Previous Clinical Trials
35 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women
2024. "Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00594373.
~20 spots leftby Apr 2025
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