HPVNCT05996016
Gut and Vaginal Microbiota Profile Study for HIV Women
An observational study of HPV and HIV Infections, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV, HIV Infections, Vaginal Microbiota
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 30 Jun 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women with HIV Infection from 6 HIV care centers across CHINA, including Beijing, Zhejiang, Guangxi, Yunan, Shanxi and Shandong.
Who may be able to join
- HIV women （including pregnant）;
- sign consent paper
Who cannot join
- virgin or maiden
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100070
Wei Lyu, MD, 13501385800 ext. 010, lvweipumch@163.com
Wei Lyu, MD
About this study
Official title: A Cohort Study Among HIV Infected Women：Exploring the Regulatory Mechanism of Gut and Vaginal Microbiota in HPV Infection and Cervical Lesion
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.
Read the detailed 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.
- Conditions
- HPV, HIV Infections, Vaginal Microbiota
- Keywords
- HPV, Women With HPV infection, vaginal microbiota, gut microbiota
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 6m, 12m, 24m, 36m
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.
Measured: 0, 6m, 12m, 24m, 36m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Jan 2017
- Primary completion1 Jan 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Lyu, MD, Principal investigator, No. 10Yi，Chaowai Street ，Chaoyang District ，Beijing ，China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996016
- Sponsor's protocol ID
- PekingUMCH-K2675
- Status last verified
- Oct 2025
- First submitted
- 28 Nov 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study Among HIV Infected Women：Exploring the Regulatory Mechanism of Gut and Vaginal Microbiota in HPV Infection and Cervical Lesion
- ClinicalTrials.gov ID
- NCT05996016
- Acronym / sponsor ID
- PekingUMCH-K2675
- Conditions
- HPV, HIV Infections, Vaginal Microbiota
- Keywords
- HPV, Women With HPV infection, vaginal microbiota, gut microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with HIV Infection from 6 HIV care centers across CHINA, including Beijing, Zhejiang, Guangxi, Yunan, Shanxi and Shandong.
Key inclusion criteria (2 listed)
- HIV women （including pregnant）;
- sign consent paper
Key exclusion criteria (1 listed)
- virgin or maiden
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | – |
Primary outcome
HPV infection incidence
Time frame: 0, 6m, 12m, 24m, 36m
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.
cervical lesions
Time frame: 0, 6m, 12m, 24m, 36m
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Lyu, MD principal investigator
No. 10Yi，Chaowai Street ，Chaoyang District ，Beijing ，China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV and HIV Infections, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Lyu, MD (13501385800 ext. 010, lvweipumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV infection incidence (time frame: 0, 6m, 12m, 24m, 36m). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.