Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1%
      Tenofovir gel with a placebo gel is an expanded safety and effectiveness trial involving 900
      young women at risk of sexually transmitted HIV infection. Participants will be provided with
      a supply of single-use, pre-filled applicators according to their randomisation. While in the
      study, participants will be asked to apply a first dose of the assigned study gel within 12
      hours prior to coitus and insert a second dose as soon as possible within 12 hours after
      coitus. All participants will receive HIV risk reduction counselling, condoms, and syndromic
      treatment of sexually transmitted infections, if required.
    

Detailed description: 
      Purpose: To assess the safety and effectiveness of tenofovir gel, a candidate vaginal
      microbicide, in sexually active women at risk for human immunodeficiency virus (HIV)
      infection in South Africa.

      Design: Phase IIb, two-arm, double-blind, randomised, controlled trial comparing 1% tenofovir
      gel with a placebo gel.

      Study Population: Sexually active, HIV-uninfected women aged 18 to 40 years in South Africa

      Study Size: 900 women

      Treatment Regimen: Participants will be provided with a supply of single-use, pre-filled
      applicators according to their randomisation. While in the study, participants will be asked
      to apply a first dose of the assigned study product, 1% tenofovir gel or placebo gel, within
      12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after
      coitus. They will be advised to use only two doses of gel in a 24-hour period.

      Study Duration: Approximately 30 months in total. Accrual will require approximately 14
      months and follow-up will continue until 92 incident HIV infections are observed in the
      study, which is expected to occur approximately 16 months after the end of the accrual
      period.

      Primary Objective:

      To evaluate the effectiveness and safety of a candidate vaginal microbicide, tenofovir gel,
      when applied intravaginally by women, in preventing sexually transmitted HIV infection.

      Secondary Objectives:

        -  To assess the impact, if any, of tenofovir gel on the incidence rate of deep epithelial
           disruption

        -  To assess the impact, if any, of tenofovir gel on viral load in women who become
           infected with HIV during the trial.

        -  To assess tenofovir resistance in HIV seroconvertors in the trial

        -  To ascertain the impact, if any, of tenofovir gel on pregnancy rates and outcomes

        -  To assess the impact, if any, of product hold at study exit on HIV infection and
           tenofovir resistance

      Ancillary Objective

      •To assess the impact, if any, of tenofovir gel in preventing sexually transmitted
      infections, including herpes simplex virus type 2 (HSV-2) and human papillomavirus (HPV)
      infections.

      Study sites:

        -  CAPRISA Vulindlela Clinical Research Site, KwaZulu-Natal, South Africa

        -  CAPRISA eThekwini Clinical Research Site, Durban, South Africa
    

Intervention name(s): Tenofovir gel; Placebo (Universal HEC placebo)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.; Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.
Other intervention name(s): Tenofovir = Viread
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: microbicides; safety; effectiveness; Tenofovir gel; HIV; young women; HIV Seronegativity