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Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00441298
First Posted: February 28, 2007
Last Update Posted: February 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
FHI 360
United States Agency for International Development (USAID)
CONRAD
Information provided by (Responsible Party):
Dr Salim S Abdool Karim, Centre for the AIDS Programme of Research in South Africa
February 27, 2007
February 28, 2007
February 1, 2016
May 2007
December 2009   (Final data collection date for primary outcome measure)
Change in HIV status compared between arms (tenofovir vs placebo) [ Time Frame: Baseline and monthly HIV testing for the duration of the study, an expected average of 18 months ]
The effectiveness of tenofovir against HIV infection will be measured by comparing the incidence of HIV in the tenofovir arm with that in the placebo arm
  • To evaluate the effectiveness and safety of a candidate vaginal microbicide,
  • tenofovir gel, when applied intravaginally by women, in preventing sexually
  • transmitted HIV infection
Complete list of historical versions of study NCT00441298 on ClinicalTrials.gov Archive Site
  • Change in incidence rate of deep epithelial disruption compared between arms [ Time Frame: Baseline and monthly assessments for the duration of the study, an expected average of 18 months ]
    To assess the impact, if any, of tenofovir gel on the incidence rate of deep epithelial disruption
  • To assess the impact of tenofovir gel on viral load [ Time Frame: measured at the first visit post HIV infection, and again 3 months later ]
    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 [ Time Frame: performed at the post-seroconversion visit ]
  • To ascertain the impact, if any, of tenofovir gel on pregnancy rates and outcomes [ Time Frame: Assessed at baseline and monthly for the duration of the study, an expected average of 18 months ]
  • To assess the impact, if any, of product hold at study exit on HIV infection and tenofovir resistance [ Time Frame: Assessed at post study visit ]
    Assess new HIV seroconversions in the period between study exit and the post study visit (range 2 to 4 months)
  • Impact of tenofovir gel on other sexually transmitted infections [ Time Frame: Change from baseline to study exit ]
    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
  • 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
Not Provided
Not Provided
 
Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV
Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa
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.

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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
HIV Infections
  • Drug: Tenofovir gel
    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.
    Other Name: Tenofovir = Viread
  • Drug: Placebo (Universal HEC placebo)
    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.
  • Experimental: 1
    Tenofovir gel (a reverse transcriptase inhibitor)
    Intervention: Drug: Tenofovir gel
  • Placebo Comparator: 2
    Universal HEC placebo
    Intervention: Drug: Placebo (Universal HEC placebo)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
889
March 2010
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-40 years (inclusive)
  • Able and willing to provide written informed consent to be screened for, and to enrol in, the study.
  • Able and willing to provide adequate locator information for study retention purposes.
  • Sexually active, defined as having had vaginal intercourse at least twice in the past 30 days prior to screening.
  • HIV negative on testing performed by study staff within 30 days of enrolment.
  • Have a negative pregnancy test which was performed by study staff within 21 days of enrolment
  • Agree to use a non-barrier form of contraceptive
  • Agree to adhere to study visits and procedures

Exclusion Criteria:

  • History of adverse reaction to latex.
  • Plans any of the following during the next 16 to 30 months (depending the anticipated date of study completion):

    • To travel away from the study site for more than 30 consecutive days.
    • To relocate away from the study site.
    • To become pregnant
    • To enrol in any other study of an investigational product or behaviour modification related to HIV prevention.
  • Has a creatinine clearance <50ml/min, as estimated using the method of Cockcroft and Gault(33).
  • Has active Hepatitis B infection (since January 2009)
  • Has a clinically apparent pelvic examination finding (observed by study staff) involving deep epithelial disruption. Otherwise eligible participants with pelvic examination findings involving deep epithelial disruption may proceed with enrolment after the findings have resolved and the inclusion/exclusion are met.
  • Has in the past year participated in any research related to any vaginally applied product/s.
  • Has current STI symptoms and/or other reproductive tract infection requiring treatment, as assessed by study staff. Otherwise eligible participants diagnosed during screening with infection(s) requiring treatment may be enrolled provided that treatment has commenced.
  • Has any other condition that, based on the opinion of the Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
 
NCT00441298
CAPRISA 004
PHSC study #9946
Yes
Not Provided
Not Provided
Dr Salim S Abdool Karim, Centre for the AIDS Programme of Research in South Africa
Centre for the AIDS Programme of Research in South Africa
  • FHI 360
  • United States Agency for International Development (USAID)
  • CONRAD
Principal Investigator: Salim S Abdool karim, MBChB, PhD CAPRISA, University of KwaZulu-Natal
Principal Investigator: Quarraisha Abdool Karim, PhD CAPRISA, University of KwaZulu-Natal
Centre for the AIDS Programme of Research in South Africa
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP