P.S. Reichelderfer, PhDHarwood, Maryland

WHIN Meeting, 2005

Fertility Regulation Update

Fertility Regulation UpdateHistorical Perspective

• January 2003 Meeting “Fertility Regulation and Systemic Hormones in HIV-infected and At-risk Women”– Contraceptive choices for HIV-infected and at-risk women– Hormonal influences on HIV acquisition– Hormonal influence on HIV disease and co-morbidities– Hormonal influence on treatment and the effect of treatments on

contraceptive methods– Hormonal influence on changes in genital tract virological/immunological

parameters and implications for transmission– What is the role of artificial insemination in HIV-discordant couples?– What is the role of hormonal menopausal therapy in HIV-infected and at-

risk women?

Contraceptive Choices

• Developing world– Depo-Provera is the most commonly used– Stigma associated with birth control of any type is the

major issue

• Developed world– Oral Contraceptives– Interaction with HIV therapeutic drugs is the major

issue

Hormonal Influences on HIV Acquisition

• Multivariate and ongoing analysis suggest contraceptive use both inject able and oral increase HIV acquisition

• “HCARAT” a prospective trial of HIV acquisition and hormonal use suggests ? (check the Lancet website at the end of the month).

Hormonal Influence on Treatment and the Effect of Treatment on Hormonal Methods

• There appears to be more rapid disease progression with women on contraceptives primarily due to selection of more “virulent/multiple strains” of virus during acute infection

• Treatment with drugs that are metabolized through the same cytochrome system as the contraceptive is contraindicated

Hormonal Influences on Genital Tract Parameters

• Shedding of virus in the genital tract (when it occurs) appears to be hormonally regulated

• Cytokines in the genital tract appear to be hormonally regulated

• Chemokine receptors (R5) appear to be up regulated by exogenous hormones

Artificial Insemination in Discordant Couples

• The major issue in the developing world is the stigma associated with a women who does not have children

• There is no incentive for male cooperation in volunteer counseling and testing for HIV

• In the developed world, the major issue is prejudice on the part of society in general and health care providers specifically

Role of Menopausal Therapy

• The major issue is that in applying the results of the large study on “normal” menopausal women we may overlook the impact on HIV-infected women, but doing the trials will be problematic from an IRB standpoint

Here and Now

• Update from the AIDS Clinical Trials Group on what they have been doing in the area of fertility regulation

• Discussion on assisted reproductive technology – leading to protocols/RO1s/RFAs/RFCs?

• On with the show!

Future Research Directions 03

• Conduct epidemiological studies on contraceptive use and needs in HIV-infected and at-risk women nationally, internationally, married and single and throughout the life cycle.

• Promote multidisciplinary studies integrating family planning and infectious disease expertise (training grants).

Future Research Directions 03 cont.

• Analyze ongoing studies on hormonal contraceptive disease acquisition and progression, and define future research based on these studies.

• Integrate studies on gender and ethnicity in clinical trials to elucidate the role of hormones versus genetics on therapy and disease course.

Future Research Directions 03 cont.

• Increase measurement studies of virological and immunological parameters in the genital tract in all clinical studies.

• Define potential studies to address the feasibility of assisted reproductive technology in serodiscordant couples, and the potential risk/benefit of hormonal therapy in HIV-infected women.