Phase 2 N=5,029 Randomized Prevention

Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women

HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00705679 ↗

Enrolled (actual)

5,029

Serious AEs

3.6%

Results posted

Feb 2016

Primary outcome: Primary: Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms — 1024; 1030 person-years

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Emtricitabine/tenofovir disoproxil fumarate (Drug); Emtricitabine/tenofovir disoproxil fumarate placebo (Drug); Tenofovir disoproxil fumarate (Drug); Tenofovir disoproxil fumarate placebo (Drug); Tenofovir 1% vaginal gel (Drug); Tenofovir placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms	1024; 1030	—
PRIMARY Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms	61; 70	—
PRIMARY Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms	6.0; 6.8	0.37
PRIMARY Person-years of Follow-up of Oral TDF and Oral Placebo Arms	823; 838	—
PRIMARY Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms	52; 35	—
PRIMARY Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms	6.3; 4.2	0.07
PRIMARY Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms	1284; 1308	—
PRIMARY Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms	61; 60	—
PRIMARY Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms	4.7; 4.6	0.81
PRIMARY Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events	4; 13; 2; 9; 3	0.004 sig
SECONDARY Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product	0; 1; 0; 0; 0; 58	—

Summary

A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) are oral, FDA-approved, anti-HIV drugs, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the safety and effectiveness of daily tenofovir 1% gel compared to a vaginal placebo gel, and the safety and effectiveness of oral TDF and oral FTC/TDF compared to an oral placebo in preventing HIV infection among women at risk for sexually transmitted infections.

Eligibility Criteria

Inclusion Criteria

Willing to provide adequate locator information
Sexually active, defined as having vaginal intercourse at least once in the 3 months prior to screening
Agree to not participate in other research studies involving drugs, medical devices, or vaginal products for duration of study.
Agree to use effective method of contraception. More information on this criterion can be found in the protocol.

Exclusion Criteria

HIV infected
Known adverse reaction to any of the study products
Known adverse reaction to latex
Pathologic bone fracture not related to trauma
Non-therapeutic injection drug use in the 12 months prior to screening
Post-exposure prophylaxis for HIV exposure within 6 months prior to enrollment
Last pregnancy outcome 42 days or less prior to enrollment
Gynecologic or genital procedure 42 days or less prior to enrollment
Participation in any other research study involving drugs, medical devices, or vaginal products 30 days or less prior to enrollment
Currently using spermicide, interferon or interleukin therapy, or certain medications. More information on this criterion can be found in the protocol.
Any significant uncontrolled active or chronic disease. More information on this criterion can be found in the protocol.
Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
Intends to become pregnant in the 24 months after enrollment
Plans to relocate or travel away from the study site for more than 8 consecutive weeks in the 24 months after enrollment
Urinary tract infection
Pelvic inflammatory disease, an STI, or reproductive tract infection requiring treatment
Grade 2 or higher pelvic exam finding
Any condition that, in the opinion of the investigator, would interfere with the study
Pregnant or breastfeeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00705679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.