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Table 2 Pre-Exposure Prophylaxis Trials in Progress.

From: Update on microbicide research and development-seeking new HIV prevention tools for women

Trial Name (Number)

Phase

Description

Location

Sponsor

No. of Subjects

Population

Intervention(s)

Results Expected

FEM-PrEP

III

Safety & effectiveness

Kenya, South Africa, Tanzania, Zimbabwe

FHI, USAID, BMGF

3900

Heterosexual women

Daily oral TDF/FTC

Q3 2013

iPrEs

III

Safety & effectiveness

Brazil, Ecuador, Peru, South Africa, Thailand, US

NIH, BMGF

2499

Men who have sex with men

Daily oral TDF/FTC

Q4 2010 [39]

Partners PrEP

III

Safety & effectiveness

Kenya, Uganda

BMGF

4700

Serodiscordant heterosexual couples

Daily oral TDF; daily oral TDF/FTC

Ql 2013

Bangkok Tenofovir Study (CDC 4370)

II/III

Safety & effectiveness

Thailand

CDC

2400

Injection drug users

Daily oral TDF

Ql 2012

VOICE (MTN 003)

IIB

Safety & effectiveness

South Africa, Uganda, Zimbabwe

MTN, NIH

5000

Heterosexual women

Daily oral TDF; daily oral TDF/FTC; daily topical tenofovir gel

Ql 2013

PrEP in YMSM (ATN 082)

II

Safety, acceptability, & feasibility

US

ATN, NICHD

99

Young men who have sex with men

Daily oral TDF/FTC

Q2 2011

TDF2 (CDC 4940)

II

Safety & adherence

Botswana

CDC

1200

Heterosexual men and women

Daily oral TDF/FTC

Q2 2011

IAVI E001 & E002

I/II

Safety, acceptability, & adherence

Kenya, Uganda

IAVI

150

Serodiscordant couples and men and women

Daily oral TDF/FTC; intermittent oral TDF/FTC (twice weekly + coital dosing)

Q4 2010

TMC278-TiDP15-C158*

I

Safety, tolerance & pharmaco-kinetics

UK

Tibotec Pharmaceucals

100

Men and women

TMC278LA injected IM

Ql 2011

  1. ATN = Adolescent Medicine Trials Network; BMGF = Bill & Melinda Gates Foundation; CDC = US Centers for Disease Control and Prevention; FHI = Family Health International;
  2. FTC = emtricitabine; IAVI = International AIDS Vaccine Initiative; MTN = Microbicide Trials Network; NICHD = National Institute of Child Health & Human Development;
  3. NIH = US National Institutes of Health; TDF = tenofovir disoproxil fumerate; USAID = United States Agency for International Development; YMSM = young men who have sex with men
  4. Reference: http://www.avac.org/ht/d/sp/a/GetDocumentAction/i/3113 (accessed december 1, 2010)
  5. *Reference: http://www.clinicaltrials.gov/ct2/show/NCT01031589?term=tmc278la%26rank=3 (accessed december 1, 2010)