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  1. Women's Health Research

OWH-Funded Research: HIV/STD

The FDA Office of Women’s Health (OWH) awards research grants for 1-2 year studies to support FDA regulatory decision-making and advance the science of women’s health. OWH has funded research projects that address health issues affecting women across their lifespan. This page highlights OWH-funded research related to HIV and other STDs.

Learn about other OWH-funded research

Bacteria and virus migration through latex condoms in the presence of personal lubricants - Srilekha Das, PhD/CDRH (16)

In the 1990s, studies were undertaken in CDRH to address the critical public health concern related to the possibility of passage of pathogenic viruses, such as HIV, hepatitis virus, and human papilloma virus, through natural rubber latex condoms. To more easily conduct the experiments, a bacteriophage, ΦX 174, of similar size and shape to the pathogenic viruses was used as a non-pathogenic test surrogate. Results of this investigation confirmed the effectiveness of intact condoms in preventing the passage of small molecules and thus, protecting consumers from sexually transmitted infections (STI). As a result, a modified version of the method was introduced in FDA guidance and an ISO standard. This method, however, did not account for the presence of personal lubricants that are often used in conjunction with condoms. Over–the–counter personal lubricants are comprised of an assortment of various chemicals; major components are usually water, glycerol, sorbitol, polyethylene or poly propylene glycol, and silicone oils, and also include a number of minor chemical components for smell, taste, and color. The presence of a personal lubricant may promote the transmission rate of small biological molecules through the thin layer of a condom by either increasing the pore size in the condom material or increasing the chemical affinity of the molecule in the external environment. In this investigation, we plan to determine if the presence of personal lubricants that may swell the latex material and change its elasticity by relaxing the polymer network, change the permeability of the membrane to ΦX 174, as well as of two of the smallest known pleomorphic (capable of changing shape) bacteria, Ureaplasma urealyticum and Mycoplasma hominis, compromising the ability of the condom to prevent transmission of STI.

Evaluation of HSV-2 co-infection and hormonal contraceptive use on HIV acquisition and pathogenesis using patient-derived clinical specimens - Indira Hewlett, PhD, CBER (13)

Women in HIV trials: a comprehensive review and meta-analysis for safety - Guoxing Soon, PhD, CDER (10)

In vitro studies to assess impact of gender and co-infection with Herpes Simplex virus type 2 on the replication and transmissibility of major emerging HIV-1 variants - Indira Hewlett, PhD, CBER (09)

Effects of B-Estradiol, on the Safety of Anti-HIV Drugs - Andrew Dayton, PhD, CBER (08)

Evaluation of gender differences in detection, replication and transmissibility of emerging HIV-1 Variants - Indira Hewlett, PhD, CBER (07)

Molecular mechanisms underlying gender-associated differences in the adverse reactions to the anti-retroviral agent, zidovudine (AZT): Role of mitochondrial toxicity - Varsha Desai, PhD, NCTR (06)

HIV SELECTEST: A novel assay for diagnosis of HIV infections in the presence of antibodies induced by candidate HIV vaccines: Evaluation of gender bias in sensitivity and specificity - Hana Golding, Ph.D. and Surender Khurana, Ph.D, CBER (06)

Sex difference dependent drug-drug interactions of anti-HIV therapeutics - Hyojong Kwon, PhD, CDER (05)

Gender Dimorphism in HIV Infection in Primary Macrophages and T-Lymphocytes: Kinetics of HIV Replication and Efficacy of Antiretroviral Agents - Andrew Dayton, PhD, CBER (04)

Thymic regeneration and immune reconstitution: Development of animal models to study the role of cytokines and hormonal contributions - Hana Golding, PhD, CBER (01)

Vaginal volume: optimizing vaginal deployment of topical microbicides - Debra Birnkrant, MD, CDER (00)

Effect of reproductive hormones on the pathogenesis and host cell interactions of Neisseria gonorrhea - Carolyn Deal, PhD, CBER (99)

Antigenic characteristics and immunogenicity of synthetic peptide vaccines for the pathogenic Neisseria: Neisseria meningitides and Neisseria gonorrhea - Margaret Bash, MD, MPH, CBER (97, 98, 99)

The role of HIV-1 co-receptors in sexual and mother-to-infant transmission - Hana Golding, PhD, CBER (97, 98)

A computer model for simulating virus transport through barriers - Matthew R. Myers, PhD, CDRH (96)

Human cytotoxic T lymphocyte recognition of Papilloma virus - Penelope Robbins, PhD, CBER (96)

Induction of mucosal immunity to protect females from HIV-1 - Basil Golding, MD, CBER (95)

Development of a method to evaluate the effect of vaccines and antiviral therapy on latent viral burden in an animal model of genital herpes - Philip R. Krause, MD, CBER (95)

Conference on STD clinical trials workshop - NIH/OEA (94)

Prevention of sexual transmission of HIV- Michael Norcross, MD, CBER (94)

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