NCT01029249

Examining the Incidence of Oral Human Papillomavirus (HPV) Shedding and Oral Warts After Beginning HAART in HIV-Infected Adults

Oral HPV Shedding and Oral Warts After Initiation of Antiretroviral Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Oral human papillomavirus (HPV) and oral warts are common health concerns for HIV-infected people. This study will examine the frequency of oral HPV DNA shedding and oral warts in HIV-infected people who are enrolled in ACTG A5257 and who are beginning treatment with highly active antiretroviral therapy (HAART).

Detailed description

Oral HPV infection occurs at a higher rate among HIV-infected people than among the general population. Recent research in the United States and Europe has also found that HIV-infected people have a higher risk of oral and oropharyngeal squamous cell cancer than HIV-uninfected people. In one study, it was found that HPV seropositivity was associated with an increased risk of squamous cell carcinoma of the oropharynx (SCCOP). In addition to SCCOP, another HPV-related health concern is oral warts, a condition for which there is no effective treatment. Even after beginning treatment with highly active antiretroviral therapy (HAART), active HPV replication in the mouth and oropharynx may persist in HIV-infected people, leading to an increased risk of SCCOP and oral warts. The purpose of this study is to evaluate the frequency of oral HPV DNA shedding and oral warts in HIV-infected people prior to HAART initiation and at regular time points after HAART initiation. ACTG A5257 is a study that is comparing the effectiveness of three non-nucleoside reverse transcriptase inhibitor (NNRTI)-sparing HAART regimens in treatment-naïve participants. This study will enroll participants from the ACTG A5257 study. Participants will attend a baseline study visit at the same time as their ACTG A5257 baseline study visit. At baseline and at Week 4, 16, 24, and 48 study visits, participants will undergo an examination of their mouth, throat wash and saliva collection, and behavioral questionnaires. A blood collection will also occur at Week 24.

Conditions

• HIV Infections

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2009-12-09
• Last updated: 2013-12-06

Locations

35 sites across 2 countries: United States, Puerto Rico