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Completed

NCT Number: NCT01029249

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

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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Puerto Rico-AIDS CRS (5401), San Juan, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet inclusion criteria for and be enrolled in ACTG A5257
  • Ability and willingness of participant or legal guardian/representative to provide informed consent

Exclusion criteria

  • Co-enrollment in A5260s
  • Has begun receiving HAART as part of the A5257 study
  • Has ever received an HPV vaccine or plans to receive an HPV vaccine in the 6 months after study entry

Treatment and study plan

Primary outcomes

  1. Type-specific oral HPV DNA shedding (presence versus absence)

    Time frame: Measured at baseline (measured at pre-entry and entry into A5257) and at Weeks 16 and 24

  2. Persistence of same type HPV DNA shedding from pre-entry/baseline visits to Week 16 and 24 visits

    Time frame: Measured at Weeks 16 and 24

Secondary outcomes

  1. Clinical diagnosis (presence versus absence) of oral warts

    Time frame: Measured at Weeks 16 and 24

  2. HPV shedding at one of the pre-HAART visits

    Time frame: Measured at one of the pre-entry visits

  3. CD4 count change (compared to baseline)

    Time frame: Measured at Weeks 4, 16, and 24

  4. Plasma HIV-1 RNA suppression

    Time frame: Measured at Weeks 4, 16, and 24

  5. Quantitative changes in HPV DNA in oral specimens obtained from participants who have the same HPV subtypes at one of the two pre-HAART visits as well as at Week 16 or 24

    Time frame: Measured at Weeks 16 or 24

  6. Clinical diagnosis (presence versus absence) or oral warts measured by a visual exam

    Time frame: Measured at baseline and Weeks 16, 24, and 48

  7. Number of oral sex partners in the last month

    Time frame: Measured at baseline and Weeks 24 and 48

  8. Number of oral sex partners in the last 6 months

    Time frame: Measured at baseline and Weeks 24 and 48

  9. Absolute CD8 count (obtained from A5257 study data)

    Time frame: Measured at Weeks 0 and 24 in the A5257 study

  10. Absolute CD4 count (obtained from A5257 study data)

    Time frame: Measured at Weeks 0, 24, and 48 in the A5257 study

  11. Percentage and absolute number of CD4 cells that are interleukin (IL)-2+/interferon (IFN)+ or transforming growth factor (TGF)+ after HPV peptide stimulation measured from peripheral blood mononuclear cells (PBMCs)

    Time frame: Measured during the A5272 study or obtained from stored specimens

  12. Percentage and absolute number of CD8 cells that are IFN, tumor necrosis factor (TNF), TGF+, or CD107+ after HPV peptide stimulation measured from PBMCs

    Time frame: Measured during the A5272 study or obtained from stored specimens

  13. Percentage and absolute number of CD4 cells that are regulatory T cells (CD4+/CD25+/CD127low) measured from PBMCs

    Time frame: Measured during the A5272 study or obtained from stored specimens

  14. Percentage of CD4 cells and CD8 cells that express CD38 and HLA-DR

    Time frame: Measured during the A5272 study or obtained from stored specimens

  15. Persistence of HPV DNA of a specific type in throat wash specimens over the time course of the study

    Time frame: Measured during the A5272 study or obtained from stored specimens

  16. Salivary total lgA and anti-HPV lgA and S-lgA titers

    Time frame: Measured during the A5272 study or obtained from stored specimens

  17. Serum total anti-HPV lgG titers

    Time frame: Measured during the A5272 study or obtained from stored specimens

Sponsors and collaborators

Lead sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Network

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Oral HPV Shedding and Oral Warts After Initiation of Antiretroviral Therapy

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 9, 2009
Registry last updated
Dec 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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