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

Information source: Centre for the AIDS Programme of Research in South Africa
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Tenofovir gel (Drug); Placebo (Universal HEC placebo) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Centre for the AIDS Programme of Research in South Africa

Official(s) and/or principal investigator(s):
Salim S Abdool karim, MBChB, PhD, Principal Investigator, Affiliation: CAPRISA, University of KwaZulu-Natal
Quarraisha Abdool Karim, PhD, Principal Investigator, Affiliation: CAPRISA, University of KwaZulu-Natal

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Change in HIV status compared between arms (tenofovir vs placebo)

Secondary outcome:

Change in incidence rate of deep epithelial disruption compared between arms

To assess the impact of tenofovir gel on viral load

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

Impact of tenofovir gel on other sexually transmitted infections

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

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

CAPRISA eThekwini Clinical Research Site, Durban, KwaZulu-Natal 4001, South Africa

CAPRISA, Vulindlela Clinical Research Site, Pietermaritzburg, KwaZulu-Natal 4013, South Africa

Additional Information

Related publications:

Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Mâsse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51.

Starting date: May 2007
Last updated: January 20, 2012

Page last updated: August 23, 2015

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