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MTN-003

Details
Protocol Title: 
Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disoproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women
DAIDS Protocol ID: 
10622
Status: 
Closed to Accrual

Protocol Chair(s)

Zvavahera Chirenje [1] (Protocol Co-Chair)
Jeanne Marrazzo [2] (Protocol Co-Chair)

Email Groups

MTN-003 ACASI User Support [3]
MTN-003 Accrual [4]
MTN-003 Adherence [5]
MTN-003 Investigator Calls [6]
MTN-003 Investigators [7]
MTN-003 Lab [8]
MTN-003 Newsletter [9]
MTN-003 Pharmacists [10]
MTN-003 Protocol Deviations [11]
MTN-003 Protocol Safety Review Team [12]
MTN-003 Publication Committee [13]
MTN-003 Safety MD [14]
MTN-003 Safety Message Board [15]
MTN-003 Safety Reports [16]
MTN-003 Study Coordinators [17]
MTN-003 Study Management Team [18]
MTN-003 Study Monitoring Committee [19]
Sites
Bothas Hill Clinical Research Site [20]
CAPRISA Aurum CRS [21]
CAPRISA eThekwini CRS [22]
Isipingo CRS [23]
Makerere University - Johns Hopkins University Research Collaboration [24]
Overport CRS [25]
Chatsworth CRS [26]
Seke South Clinical Research Site [27]
Soweto MTN CRS [28]
Spilhaus Clinical Research Site [29]
Tongaat CRS [30]
Umkomaas Clinical Research Site [31]
Verulam CRS [32]
Wits Reproductive Health and HIV Institute (WRHI) [33]
Zengeza 3 Clinic [34]
Countries
South Africa [35]
Uganda [36]
Zimbabwe [37]
Description
Vaginal and Oral Interventions to Control the Epidemic (VOICE)

The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic –is the first study to compare the safety and efficacy of oral versus topical pre-exposure prophylaxis (PrEP) for prevention of sexual transmission of HIV. VOICE is designed as a five-arm, double-blinded study in which women are first randomized to receive either gel or oral PrEP, and then within each group, randomly assigned to either tenofovir 1% topical gel or placebo gel; or to oral tenofovir(tenofovir disoproxil fumarate), oral Truvada (emtricitabine/tenofovir disoproxil fumarate)  or oral placebo. The study will enroll 5,000 women at various study sites in Africa.

Other Study Info

Sponsors:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US Eunice Kennedy Shriver National Institute of Child Health and Human Development

US National Institute of Mental Health

US National Institutes of Health

Co-Sponsors:

CONRAD, Gilead Sciences, Inc.

Study Design:

Phase 2B, five-arm, double-blinded, placebo-controlled, multi-site, randomized, controlled trial

Printer-friendly version [38]
Source URL: http://www.mtnstopshiv.org/studies/70

Links:
[1] http://www.mtnstopshiv.org/users/zchirenje
[2] http://www.mtnstopshiv.org/users/jmarrazzo
[3] http://www.mtnstopshiv.org/people/emailgroups/103
[4] http://www.mtnstopshiv.org/people/emailgroups/117
[5] http://www.mtnstopshiv.org/people/emailgroups/122
[6] http://www.mtnstopshiv.org/people/emailgroups/86
[7] http://www.mtnstopshiv.org/people/emailgroups/73
[8] http://www.mtnstopshiv.org/people/emailgroups/94
[9] http://www.mtnstopshiv.org/people/emailgroups/146
[10] http://www.mtnstopshiv.org/people/emailgroups/92
[11] http://www.mtnstopshiv.org/people/emailgroups/124
[12] http://www.mtnstopshiv.org/people/emailgroups/100
[13] http://www.mtnstopshiv.org/people/emailgroups/213
[14] http://www.mtnstopshiv.org/people/emailgroups/121
[15] http://www.mtnstopshiv.org/people/emailgroups/98
[16] http://www.mtnstopshiv.org/people/emailgroups/78
[17] http://www.mtnstopshiv.org/people/emailgroups/74
[18] http://www.mtnstopshiv.org/people/emailgroups/83
[19] http://www.mtnstopshiv.org/people/emailgroups/131
[20] http://www.mtnstopshiv.org/sites/50
[21] http://www.mtnstopshiv.org/sites/1071
[22] http://www.mtnstopshiv.org/sites/1327
[23] http://www.mtnstopshiv.org/sites/908
[24] http://www.mtnstopshiv.org/sites/60
[25] http://www.mtnstopshiv.org/sites/909
[26] http://www.mtnstopshiv.org/sites/76
[27] http://www.mtnstopshiv.org/sites/73
[28] http://www.mtnstopshiv.org/sites/1602
[29] http://www.mtnstopshiv.org/sites/74
[30] http://www.mtnstopshiv.org/sites/1419
[31] http://www.mtnstopshiv.org/sites/52
[32] http://www.mtnstopshiv.org/sites/1420
[33] http://www.mtnstopshiv.org/sites/1073
[34] http://www.mtnstopshiv.org/sites/739
[35] http://www.mtnstopshiv.org/node/3558
[36] http://www.mtnstopshiv.org/countries/uganda
[37] http://www.mtnstopshiv.org/countries/zimbabwe
[38] http://www.mtnstopshiv.org/print/70

Media Contacts:

Lisa Rossi -- Office: +1 412 641-8940 -- Mobile: +1 412 916-3315 -- Email: rossil@upmc.edu

Clare Collins -- Office: +1 412 641-7299 -- Mobile: +1 412 770-8643 -- Email: collcx@upmc.edu