NCT00262106

An International Multi-centre, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of 0.5% and 2% PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection

Completed Phase 3 Last updated 5 September 2012

What this trial tests

Phase 3 trial testing PRO 2000/5 in HIV Infections in 9,404 participants. Completed in 1 September 2009.

Timeline

1 October 2005

Primary endpoint
1 August 2008

1 September 2009

Quick facts

Lead sponsor	Endo USA Inc., a Keenova Therapeutics Company
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	9,404
Start date	1 October 2005
Primary completion	1 August 2008
Estimated completion	1 September 2009
Sites	6 locations across South Africa, Tanzania, Uganda, Zambia

Drugs / interventions tested

• PRO 2000/5
• Placebo

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• Gonorrhea — all drugs for Gonorrhea →
• Chlamydial Infections — all drugs for Chlamydial Infections →
• Genital Herpes — all drugs for Genital Herpes →

Sponsor

Endo USA Inc., a Keenova Therapeutics Company

Who can join

16 and older, female only, with HIV Infections or Gonorrhea. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Acquisition of HIV infection before or at the 12 month time point, confirmed in a central laboratory, in participants confirmed to be HIV negative at enrollment
  Time frame: 12 months
• Grade 3 (severe) or 4 (life-threatening) clinical or laboratory adverse event confirmed on examination or repeat testing, respectively
  Time frame: 12 months

Sponsor's own description

The objective of the study is to determine the efficacy and safety of 0.5% and 2% PRO 2000/5 gels compared to placebo in preventing vaginally acquired HIV infection.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vaginal microbicides and the prevention of HIV transmission.
   Cutler B, Justman J. · · 2008 · cited 108× · PMID 18992405 · DOI 10.1016/s1473-3099(08)70254-8
2. Controlling the HIV/AIDS epidemic: current status and global challenges.
   Demberg T, Robert-Guroff M. · · 2012 · cited 18× · PMID 22912636 · DOI 10.3389/fimmu.2012.00250
3. HIV-1 Entry and Prospects for Protecting against Infection.
   Bruxelle JF, Trattnig N, Mureithi MW, Landais E, et al · · 2021 · cited 10× · PMID 33499233 · DOI 10.3390/microorganisms9020228
4. siRNA-based topical microbicides targeting sexually transmitted infections.
   Katakowski JA, Palliser D. · · 2010 · cited 10× · PMID 20373263
5. Women design their own vaginal microbicide trial: Suggestions on how to improve adherence from former participants of HIV prevention trials.
   Miller L, Morar N, Kapiga S, Ramjee G, et al · · 2021 · cited 7× · PMID 33411782 · DOI 10.1371/journal.pone.0244652