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MDP
302 Study Information
18 April 2011
Update on MDP 302
MDP partners in Mozambique, Tanzania, Uganda and Zambia have completed
the Top Up study which assessed gel adherence and adherence measurement
tools. The clinical research sites are preparing to implement the MDP
302 clinical trial before the end of the year, pending a funding
decision. MDP 302 is a randomised, placebo-controlled trial of 1%
tenofovir (TFV) vaginal gel which will evaluate the effectiveness of a
single dose of tenofovir gel applied prior to sex compared to placebo.
It will also assess the relative effectiveness of a single dose
compared to the dual dosing (BAT24) that offered 39% protection against
HIV infection in the CAPRISA 004 trial. The aim of MDP 302 is to
provide information to support implementation post licensure.
The MDP 302 trial will:
-
assess ONE dose of tenofovir vaginal gel per sex act compared to
placebo
-
include TWO doses per sex act as we know this provided protection in
CAPRISA 004 study populations
-
include 16-17yr olds, and pregnant women (subject to national
approvals)
-
include women from Mozambique, Uganda, Tanzania and Zambia –
3 of these countries have no current experience of tenofovir gel
-
reduce the frequency of the clinic visits and tests to get closer to a
feasible roll-out schedule
The MDP 302 study design has been through peer review and the updated
study design is described on the following documents:
MDP partners in
Mozambique, South Africa, Tanzania, Uganda and Zambia
are in the latter stages of the Top Up study which is assessing gel
adherence and adherence measurement tools. At the end of Top Up the
clinical research sites hope to roll over into the MDP 302 clinical
trial, but this is subject to funding. MDP 302 design is a randomised,
placebo-controlled efficacy trial of 1% tenofovir (TFV) gel which will
evaluate the effectiveness of a single dose of tenofovir gel applied
prior to sex compared to placebo, as well as the relative effectiveness
of a single dose compared to the dual dosing (BAT24) that offered 39%
protection against HIV infection in the CAPRISA 004 trial. The aim of
MDP 302 is to provide information to support implementation post
licensure.
The MDP 302 trial will:
- assess ONE dose of tenofovir vaginal gel
per sex act compared to placebo
- include TWO doses per sex act as we know
this provided protection in CAPRISA 004 study populations
- include 16-17yr olds and women from
Mozambique,
Uganda, Tanzania and Zambia as well as South Africa – 3 of
these
countries have no current experience of tenofovir gel
- reduce the frequency of the clinic visits
and tests to get closer to a feasible roll-out schedule
The following MDP 302
study documents are available:
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