Population Council Research that makes a difference

2011 International Conference on Family Planning
29 November–2 December 2011

Abstract

"MPTs in clinical development for use in low resource settings"
Jill Schwartz and Tom Zydowsky

Background
There is an urgent need to develop safe, acceptable, effective, and low-cost MPTs to protect against a variety of SRH risks. Two innovative MPT strategies currently under development are: 1) using a contraceptive barrier to deliver microbicides; and 2) combining microbicidal and contraceptive drugs into one product for on demand or sustained use.

Methods
CONRAD plans to test the SILCS diaphragm as a reusable delivery system for Tenofovir (TFV) 1% gel to provide both barrier contraceptive protection and a microbicide at the same time. TFV gel is the first vaginal microbicide shown to be effective in preventing HIV-1 and HSV-2 in women, and SILCS is an innovative single-sized diaphragm that is safe and effective when used with a contraceptive gel. CONRAD also is developing a three-month intravaginal ring (IVR) that releases both the contraceptive hormone levonorgestrel (LNG) and TFV. LNG is an ideal contraceptive to use in a MPT, given its excellent safety and efficacy record, physical stability, steady release rate, and low cost.

The Council is developing a pre-coital MPT gel for women who have sex intermittently. This gel would combine LNG with two effective antiviral agents [an NNRTI (MIV-150), and zinc acetate (ZA)] that would limit the emergence and impact of drug-resistant viruses and provide a one-two punch against HIV and HSV-2. The Council is also developing this combination of drugs as an IVR.

Results
CONRAD’s SILCS and TFV gel studies will show how well this new diaphragm delivers gel compared to an applicator, and whether SILCS used with TFV gel is an effective contraceptive. CONRAD’s IVR research will evaluate whether TFV can be combined with a contraceptive in a single vaginal ring for sustained delivery over a three-month period.

The Council’s macaque studies of its MIV-150+ZA gel show that a single dose prevents vaginal infection for up to 24 hours, and that a MIV-150 IVR provides significant protection. Moreover, the MIV-150+ZA gel prevented HSV-2 infection in mice. Clinical studies of LNG in a gel or IVR confirm the feasibility of reaching appropriate serum levels to prevent conception. The Council intends to combine these three agents into an on-demand gel and a three-month IVR to prevent conception, HIV and HSV-2.

Conclusions
These innovative MPT strategies in clinical development have the potential to protect against unintended pregnancy, HIV and HSV-2. If successful, these products would substantially improve reproductive health for women and girls in low resource settings.

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