Collection of Biological Specimens for Development and Validation of Laboratory Procedures to Support Future Clinical Research Studies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laboratory Procedure Development and Validation
- Sponsor
- University of Pittsburgh
- Enrollment
- 245
- Locations
- 1
- Primary Endpoint
- Validation of Laboratory Procedures
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Biologic samples are necessary for development and validation of laboratory procedures (e.g. novel biological and analytical assays, explant tissue models, validation of specimen collection and transport) to support future infectious disease clinical studies. In this research study, the investigators will collect blood samples, vaginal swabs, cervical swabs, mucus/vaginal discharge, cervicovaginal lavages, vaginal and cervical biopsies, as necessary, to use in the development of laboratory processes. The investigators will obtain the sample(s) from healthy HIV negative women. Samples will be collected and sent to Magee-Womens Research Institute as laboratory specimens are needed.
Investigators
Katherine Bunge
Assistant Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Control Group (post-menopausal) Inclusion:
- •Females, age greater than 50 years
- •Non-pregnant
- •Post-menopausal defined as no menses or vaginal bleeding for at least 1 year
- •Agree to have HIV testing or have documentation of a negative HIV test result within the past 6 months.
- •Free from participant report and clinician observed abnormal discharge or other vaginal symptoms (with the exception of vaginal dryness) on the day of genital sample collection.
- •Willing and able to provide written informed consent.
- •Willing to provide contact information for receipt of laboratory results, as applicable.
- •Reproductive-aged Group Inclusion Criteria:
- •Females, 18-45 years of age
Exclusion Criteria
- •Control Group (post-menopausal) Exclusion Criteria:
- •Use of hormone replacement therapy, including oral, vaginal and transdermal.
- •Hysterectomy.
- •An active urogenital infection within the past 14 days, including:
- •Vaginal infections (symptomatic candidiasis, trichomonas vaginalis, and bacterial vaginosis).
- •Cervical infections (Gonorrhea (GC), Chlamydia (CT) or mucopurulent cervicitis (MPC)).
- •HSV/Genital Warts
- •Urinary Tract Infection
- •Recent exposure to a partner with GC, CT, trichomonas, syphilis, non-gonococcal urethritis, or HIV.
- •Use of systemic or vaginal antibiotics or antifungals 14 days prior to genital sample collection.
Outcomes
Primary Outcomes
Validation of Laboratory Procedures
Time Frame: up to 5 years
The primary aim of this study is to collect an adequate number of biological samples, as needed by investigators, to support development and validation of laboratory procedures necessary for upcoming topical microbicide and infectious disease research clinical trials.