|
Study population |
Location |
Route of HIV
transmission |
Intervention |
Outcome |
Comments |
CAPRIS
A 0042 |
889 heterosexual women at high
risk of infection, aged 18-40years |
South Africa |
Vaginal |
Coltally-dependent
TFV 1% gel (two doses
up to 12h precoitus
and postcoitus) |
39% protection; 54%
protection calculated
in participants using
>80% of doses |
High TFV-DP concentration
in vaginal and cervical tissue
critical for efficacy |
iPrEX4 |
2499 MSM at high risk of infection;
approximately 70% of mixed ethnicity;
mean age in TDF/FTC group
27-5years |
North and South
America, Thailand,
South Africa |
Rectal/penile |
Daily oral TDF/FTC |
44% protection; 92%
protection calculated
for subjects
with detectable drug
concentrations |
High TFV-DP concentrations
in rectal tissue might be critical
for efficay |
TDF25 |
1200 sexually active adults; 55%
male, 45% female; 94% unmarried;
approximately 90% age 21-29years |
Botswana |
vaginal/penile |
Daily oral TDF/FTC |
63% protection |
>30% did not complete
study; cannot draw definitive
conclusions for women and
men separately |
PIP6 |
4747 heterosexual serodiscordant
couples; 38% negative-female,
68% negative-male partner, 98%
married; median age 33years |
Botswana, Kenya,
Rwanda, South Africa,
Tanzania, Uganda,
zambia |
vaginal |
Daily oral TDF or TDF/
FTC |
62% protection with
TDF alone; 73% protection
with TDF/FTC |
Discordant couples may be a
distinct, unique population |
FEM-PrEP7 |
1951 heterosexual women at high
risk of infection aged 18-35 years |
Kenya, South Africa,
Tanzania |
vaginal |
Daily oral TDF/FTC |
Trail discontinued for
futility in April, 2011 |
Adherence assessment with
monthly clinical samples to
measure drug concentration
is pending |
VOICE
(MTN-003)3 |
5029 heterosexual
women aged
18-45 years |
Uganda, South Africa,
Zimbabwe |
vaginal |
Daily oral TDF or daily
oral TDF/FTC or daily
topical TFV gel |
Oral TDF group discontinued
for futility in
September, 2011; TFV
1% gel and placebo gel
groups discontinued
for futility in November,
2011; oral TDF/FTC
group continues |
For TDF, the tissue concentration
may be critical;
for TFV 1% gel, adherence
analysis is pending |
HPTN 0521 |
1763 heterosexual serodiscordant
couples; 50% negative- females,
50% negative-male partner; 94%
married; 61% aged 26-40 years |
Bostwana, Kenya,
Malawi, South Africa,
Zimbabwe, Brazil,
India, Thailand |
Vaginal/Penile |
Immediate or delayed
ART in HIV-infected
partner |
96% protection |
Suppression of viraemia on
therapy assured by routine
monitoring |
MSM=Men who have Sex with Men. TDF=Tenofovir Disoproxil Fumarate. TFV=Tenofovir. TFV-DP= Tenofovir Diphosphate.
FTC=Emtricitabine. ART= Antiretroviral Therapy |