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HPTN 035
Phase II/IIb Safety and
Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO2000/5 Gel
(P) for the Prevention of HIV Infection in Women
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The
HPTN's microbicide agenda, including HPTN 035, is transitioning to the
Microbicide Trials
Network (MTN). Information on current HPTN microbicide trials will
be maintained on the HPTN website until this transition process is
complete.
What is HPTN 035?
Topical
microbicides are antimicrobial agents formulated for application to the surface
of the vagina and/or rectum for the prevention of HIV transmission during sexual
intercourse. This prevention strategy is urgently needed throughout the world
because many individuals at high risk of transmitting or acquiring HIV infection
cannot or will not use condoms with every act of sexual intercourse. Reasons for
lack of effective condom use include power imbalances in relationships that
result in the inability of the receptive partner to negotiate condom use,
physical discomfort and decreased sexual pleasure.
HPTN
035 is Phase II/IIb, four-arm, multisite, randomized controlled trial
comparing BufferGel and 0.5% PRO 2000/5 Gel (P) with a placebo gel and
with no gel.
This study will recruit sexually active HIV-uninfected women from
the following countries: Malawi,
South Africa, Zambia, Zimbabwe, and the U.S.
The primary objective of HPTN 035 is to determine the safety and
effectiveness of two candidate vaginal microbicides: BufferGel and 0.5%
PRO 2000 Gel (P).
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Protocol Status:
Closed to Accrual
Study Summary
Study Purpose: To determine the safety and effectiveness of two candidate vaginal microbicides: BufferGel and 0.5% PRO 2000 Gel (P).
Study Design: Phase II/IIb, four-arm, multisite, randomized controlled trial comparing BufferGel and 0.5% PRO 2000/5 Gel (P) with a placebo gel and with no treatment. The three study gel arms will be double-blinded. The Phase II portion of the study will be conducted as an uninterrupted lead-in to the Phase IIb portion. Each study participant will complete approximately 12-30 months of follow-up.
Study Population: Sexually active HIV-uninfected women from the following study sites: Blantyre, Malawi; Lusaka, Zambia; Chitungwiza and Harare, Zimbabwe; Durban and Hlabisa, South Africa; Lilongwe, Malawi; Philadelphia, PA, USA
Study Size: Approximately 3220 women total, 800 of whom will take part in the Phase II portion of the study.
Study Duration: Approximately 30 months total. Accrual will require approximately 18 months and follow-up will continue until 192 incident infections are observed in the study, which is expected to occur approximately 12 months after the end of the accrual period.
Treatment Regimen: Participants assigned to the three study treatment arms will apply a single dose of the product BufferGel, PRO 2000/5 Gel (P), or placebo gel intravaginally up to 60 minutes before each act of vaginal intercourse while in the study, using single-use, pre-filled applicators. Participants in all four groups will receive ongoing HIV risk reduction counseling, condoms, and diagnosis and treatment of sexually transmitted diseases.
Primary Objectives: To evaluate the safety of BufferGel and 0.5% PRO2000/5 Gel (P) when applied intravaginally by women at risk for sexually-transmitted HIV infection.
To estimate the effectiveness of BufferGel and 0.5% PRO 2000/5 Gel (P) in preventing HIV infection among at-risk women.
Secondary Objectives: To estimate the effectiveness of BufferGel and 0.5% PRO 2000/5 Gel (P) in preventing the following among women at risk for sexually-transmitted HIV infection: Bacterial vaginosis, Chlamydia infection, Genital ulcer disease, Gonorrhea infection, Herpes simplex virus-2 infection, Pregnancy, Syphilis infection, Trichomoniasis.
To assess the acceptability of BufferGel and 0.5% PRO 2000 Gel (P) for use as a vaginal microbicide.
SDMC Protocol Specialist:
Corey Leburg
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SDMC Protocol Specialist:
Missy Cianciola
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Protocol Co-Chair:
Gita Ramjee
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Protocol Co-Chair:
Irving Hoffman
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Protocol Co-Chair:
Lisa Maslankowski
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Protocol Co-Chair:
Muzala Kapina
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Protocol Co-Chair:
Nancy Padian
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Protocol Co-Chair:
Taha Taha
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Protocol Chair:
Salim S. Abdool Karim
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DAIDS Medical Officer:
Lydia Soto-Torres
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DAIDS Medical Officer:
Sheryl Zwerski
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CORE Protocol Specialist:
Anne Coletti
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CORE Protocol Specialist:
Kailazarid Gomez
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