Anal HPV Infection and Risk for Anal High-grade Squamous Intraepithelial Lesion Among Thai MSM With Acute HIV Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03032575|
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus Infection||Behavioral: SEARCH010/RV254||Not Applicable|
Anal human papillomavirus (HPV) infection is very common in men who have sex with men (MSM).1-3 HIV-positive MSM have a higher prevalence of anal HPV infection than HIV-negative MSM and are more likely to have infection with multiple HPV types.1,2 Spontaneous clearance of anal HPV infection is less common among HIV- positive compared with HIV-negative MSM.2 Persistent anal HPV infection, particularly with high-risk HPV types, is an important risk factor for the development of anal cancer.4-6 The incidence of anal cancer among HIV-positive MSM is very high, ranging from 75 to 137 per 100,000 person-years, and is five times higher than that in HIV-negative MSM.7-10 Anal high-grade squamous intraepithelial lesion (HSIL) is the putative precursor of anal cancer.11-13 Anal squamous intraepithelial lesion has a dynamic picture of temporal progression and regression, but HSIL is much less likely to regress than low-grade squamous intraepithelial lesion (LSIL).10,14 A recent systematic review and meta-analysis showed the pooled prevalence of anal HSIL to be 29.1% in HIV-positive MSM and 21.5% in HIV-negative MSM.15 Anal HSIL incidence ranged from 8.5 to 15.4% per year in HIV-positive MSM and 3.3 to 6.0% per year in HIV-negative MSM. Although data are limited, previous studies have shown a 9-15% progression rate from anal HSIL to anal cancer during a median follow-up of 3 - 5 years. 11-13 Previous research at the Thai Red Cross AIDS Research Centre has demonstrated high rates of HPV infection and anal HSIL among Thai MSM, with HIV-positive MSM disproportionately affected. Prevalence of anal infection with high-risk HPV types was 57.5% in HIV-positive and 36.6% in HIV-negative MSM (p = 0.008).16 Prevalence of anal HSIL was 18.9% in HIV-positive MSM and 11.4% in HIV-negative MSM (p = 0.1), while incidence of anal HSIL over 12 months was 29% and 8%, respectively (p=0.001).17 HIV-positive MSM in that study, however, were mainly naïve to antiretroviral therapy (ART) at enrollment (87% not on ART) and only 10% had undetectable HIV viral load at baseline.
It is not clear if the higher rates of HPV infection and persistence of infection are due to HIV infection or to different risk behavior among HIV-positive MSM. Data are inconclusive on whether the use of ART has an effect on anal HPV infection among HIV-positive MSM.18-19 Furthermore, there is no data on the effect that "early diagnosis" of HIV infection and "early treatment" with ART might have on incidence and persistence of HPV infection or on the development of anal HSIL.
We propose a longitudinal, observational study of HPV infection and anal HSIL among HIV-positive Thai MSM who initiate ART during acute HIV infection (AHI). The hypothesis is that early HIV diagnosis and early ART within the first 4 weeks of infection will mitigate immunological and virological factors that increase HPV persistence and anal HSIL incidence in HIV-positive MSM such that these measure will be significantly lower when compared to historical controls of chronically-infected HIV-positive Thai MSM.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SEARCH Thailand and Thai Red Cross AIDS Research Centre|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||October 2021|
sample size 100
Study Design: This is a prospective observational cohort of Thai MSM who initiated ART at the time of AHI, defined as the first 30 days after HIV acquisition (Fiebig stages 1 through 5). Volunteers will be examined at baseline to determine the prevalence of HPV infection and HSIL at HIV diagnosis. They will then be followed longitudinally for new incidence of HPV and HSIL, as well as progression or regression of existing lesions.
- The prevalence and incidence of anal HSIL among MSM who initiate ART during AHI will be lower than among chronically-infected HIV-positive MSM, Anal HSIL is diagnosed based on histology specimen and cytology (2001 Bethesda system) [ Time Frame: 12 months ]
The prevalence of anal HSIL and the incidence of anal HSIL during the follow-up period. Anal HSIL is diagnosed based on histology specimen. A composite anal HSIL outcome (including both cytologic HSIL/ASC-H and histologic HSIL) will also be used.
Incidence of HSIL during the follow-up period will be calculated as the number of new diagnoses per person time at risk. 95% confidence intervals (CI) will be calculated assuming a Poisson distribution. Cox proportional hazards regression will be used to identify factors associated with incident HSIL.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032575
|Contact: Nittaya Phanuphak, M.D.,Ph.D.||881 825 firstname.lastname@example.org|
|Contact: Siriporn Nonenoy, MPH||881 818 email@example.com|
|The Thai Red Cross AIDS Research Centre||Recruiting|
|Pathum Wan, Bangkok, Thailand, 10330|
|Principal Investigator:||Nittaya Phanuphak, M.D.,Ph.D.||The Thai Red Cross AIDS Research Centre|