Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An interim review of the data revealed that there was broad inter-participant variability.The study was stopped due to futility.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
This study will evaluate the impact of hormonal contraceptives on HIV risk associated with changes to the innate immunity in the female genital tract in a cross-sectional study. HIV risk will be evaluated by the capacity of cervical tissue to replicate HIV when challenged ex vivo and correlated to the number of CD4 T cells, DCs, and macrophages; the capacity of cervicovaginal fluid to inhibit HIV will be correlated to soluble mucosal mediators, and the vaginal microbiota. The lower genital tract samples will be collected from 120 adolescents aged 18-19 (40 using no hormonal contraception, 40 using ENG-I, 40 using LNG-IUS). For comparison, 90 adult women aged 25-45 will be equally distributed between the same groupings.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No contraception/18-19 years old | |||
| Use of ENG-I/18 - 19 years old | |||
| LNG-IUS/18-19 years old | |||
| No Contraception/ 25 - 45 years old | |||
| Use of ENG-I/25 - 45 years old | |||
| LNG-IUS/25-45 years old |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| HIV replication in cervical tissue as measured by levels of HIV p24/viral transcripts | cervical tissue testing | baseline |
| number of immune cells in cervical tissue, including CD45, CD3, CD4, and CD8 and their expression of CCR5, CCR6 and CD69, and CD11c+ DCs and CD14+ macrophages | cervical tissue testing | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of bacterial vaginosis defined as a Nugent score ≥7 on a vaginal smear | vaginal specimen | baseline |
| prevalence and quantity of lactobacillus species and bacterial vaginosis associated bacteria as measured by traditional culture methods and quantitative PCR |
Not provided
Inclusion Criteria:
Meets one of the following age groups (at the time of sample collection):
Meets one of the following contraception groups:
HIV uninfected Note: HIV testing will be done as part of screening. However, if a woman participated in a recent research study and has an HIV test result available from that study, this will suffice provided the date of the test is within 6 months of the study visit.
Willing to undergo pelvic exam and collection of cervical biopsies
Willing to provided written informed consent
Agree to be sexually abstinent for 48 hours prior to the cervical biopsies and for one week after the biopsies.
Exclusion Criteria:
Not provided
participants must have a cervix for participation
non-pregnant, HIV negative, healthy 18-19 year old women and 25-45 year old women
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katherine Bunge, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
vaginal specimen |
| baseline |
| HIV inhibitory activity in mucosal fluid; and soluble mucosal factors identified through pathway analyses and confirmed by targeted ELISA/multiplexing technology (proteases/ anti-proteases, keratin, IFNε, and other molecules) | mucosal fluid | baseline |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |