NCT00074425

Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel (P) for the Prevention of HIV Infection in Women

Completed Phase 2 Last updated 3 November 2021

What this trial tests

Phase 2 trial testing BufferGel in HIV Infections in 3,101 participants. Completed in 1 September 2008.

Timeline

1 January 2005

Primary endpoint
1 September 2008

1 September 2008

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	prevention
Enrollment	3,101
Start date	1 January 2005
Primary completion	1 September 2008
Estimated completion	1 September 2008
Sites	8 locations across United States, Malawi, South Africa, Zambia, Zimbabwe

Drugs / interventions tested

• BufferGel — full drug profile →
• PRO 2000/5 Gel — full drug profile →
• Placebo gel

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

18 and older, female only, with HIV Infections. Healthy volunteers can join.

What's being measured

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

• Safety of BufferGel and 0.5% PRO 2000/5 Gel (P), as assessed by deep epithelial disruption, other genital symptoms, or other systemic symptoms
  Time frame: Throughout study
• HIV infection as measured by seroconversion
  Time frame: Throughout study

Sponsor's own description

The majority of HIV infected people worldwide became infected with the virus through heterosexual contact. BufferGel and PRO 2000 Gel are vaginal gels designed to prevent women from becoming infected with HIV during sexual intercourse with an HIV infected partner. This study will test the safety and effectiveness of these gels.

Publications & conference data

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

1. Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women.
   Abdool Karim SS, Richardson BA, Ramjee G, Hoffman IF, et al · · 2011 · cited 174× · PMID 21330907 · DOI 10.1097/qad.0b013e32834541d9
2. An Empiric HIV Risk Scoring Tool to Predict HIV-1 Acquisition in African Women.
   Balkus JE, Brown E, Palanee T, Nair G, et al · · 2016 · cited 142× · PMID 26918545 · DOI 10.1097/qai.0000000000000974
3. 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
4. Bacterial vaginosis and the risk of trichomonas vaginalis acquisition among HIV-1-negative women.
   Balkus JE, Richardson BA, Rabe LK, Taha TE, et al · · 2014 · cited 66× · PMID 24413493 · DOI 10.1097/olq.0000000000000075
5. HIV-1 specific IgA detected in vaginal secretions of HIV uninfected women participating in a microbicide trial in Southern Africa are primarily directed toward gp120 and gp140 specificities.
   Seaton KE, Ballweber L, Lan A, Donathan M, et al · · 2014 · cited 29× · PMID 25054205 · DOI 10.1371/journal.pone.0101863
6. HPTN 035 phase II/IIb randomised safety and effectiveness study of the vaginal microbicides BufferGel and 0.5% PRO 2000 for the prevention of sexually transmitted infections in women.
   Guffey MB, Richardson B, Husnik M, Makanani B, et al · · 2014 · cited 20× · PMID 24898857 · DOI 10.1136/sextrans-2014-051537
7. Mucosal Escherichia coli bactericidal activity and immune mediators are associated with HIV-1 seroconversion in women participating in the HPTN 035 trial.
   Dezzutti CS, Richardson BA, Marrazzo JM, Tugetman J, et al · · 2012 · cited 19× · PMID 22966121 · DOI 10.1093/infdis/jis555
8. Appropriateness of hydroxyethylcellulose gel as a placebo control in vaginal microbicide trials: a comparison of the two control arms of HPTN 035.
   Richardson BA, Kelly C, Ramjee G, Fleming T, et al · · 2013 · cited 18× · PMID 23334506 · DOI 10.1097/qai.0b013e31828607c5