Gut and Vaginal Microbiota Profile Study for HIV Women

HIV Infections Clinical Trial

Official title:

A Cohort Study Among HIV Infected Women：Exploring the Regulatory Mechanism of Gut and Vaginal Microbiota in HPV Infection and Cervical Lesion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996016
• Other study ID #: PekingUMCH-K2675
• Status: Recruiting
• Start date: November 9, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: November 2022
• Source: Peking Union Medical College Hospital
• Contact: Wei Lyu, MD
• Phone: 13501385800
• Email: lvweipumch[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Women Living with HIV Infection （WLHIV）are intended to acquire HPV infection which usually contributes to variable cervical lesions. we hypothesize that vaginal microbiota imbalance may make WLHIV prone to HPV infection，thereafter results in severe cervical lesion.

Description:

Women Living with HIV Infection （WLHIV）are intended to acquire HPV infection which usually contributes to variable cervical lesions. Besides the HPV co-infection, microbiota study recently reveals that the changes of vaginal bacteria spectrum might also be related with cervical disease in WLHIV. However, data on HPV prevalence in WLHIV and its associated cervical lesion incidence is still limited in China. Moreover, the causal relationship between vaginal microbiota and cervical lesion in WLHIV is not clear. Here, we hypothesize that vaginal microbiota imbalance may make WLHIV prone to HPV infection，thereafter results in severe cervical lesion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 31, 2026
• Est. primary completion date: November 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• HIV women (including pregnant);

• sign consent paper

Exclusion Criteria:

• virgin or maiden

Related Conditions & MeSH terms

• HIV Infections
• HPV
• Infections
• Vaginal Microbiota

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV infection incidence	To collect 400 analyzable samples from women with HIV, including HPV screening, fecal and vaginal microflora samples. Cervical HPV screening will be collected as required in standard containers and stored for transport to the central laboratory.the rates of HPV infection.	0, 6m, 12m, 24m, 36m
Primary	cervical lesions	To collect 400 analyzable samples from women with HIV, including vaginal cleanliness assessment and TCT examination. vaginal swab samples will be collected as required in standard containers and stored for transport to the central laboratory.Variable cervical lesions, including CIN I-III and neoplasma.	0, 6m, 12m, 24m, 36m