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HIV InfectionsNCT01029249

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

An observational study of HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 35 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
How many people
500 participants
Where
35 sitesin 2 countries
Study dates
Jan 2010to May 2013
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants in this study will also be enrolled in ACTG A5257.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

United States34 sites

  • The Ponce de Leon Ctr. CRS (5802)

    Atlanta, Georgia, 30308

  • IHV Baltimore Treatment CRS (4651)

    Baltimore, Maryland, 21201

  • Alabama Therapeutics CRS (5801)

    Birmingham, Alabama, 35294-2050

  • Beth Israel Deaconess Medical Center ACTG CRS (103)

    Boston, Maryland, 02215

  • Massachusetts General Hospital ACTG CRS (101)

    Boston, Massachusetts, 02114

  • Cooper Univ. Hosp. CRS (31476)

    Camden, New Jersey, 08103

  • University of North Carolina AIDS CRS

    Chapel Hill, North Carolina, 27514

  • Northwestern University CRS (2701)

    Chicago, Illinois, 60611

  • Rush University Medical Center (2702)

    Chicago, Illinois, 60612

  • University of Cincinnati CRS

    Cincinnati, Ohio, 45267

  • Case CRS (2501)

    Cleveland, Ohio, 44106

  • MetroHealth CRS (2503)

    Cleveland, Ohio, 44109

  • The Ohio State University AIDS CRS (2301)

    Colombus, Ohio, 43210

  • Henry Ford Hosp. CRS (31472)

    Detroit, Michigan, 48202

  • Duke Univ. Med. Ctr. Adult CRS (1601)

    Durham, North Carolina, 27710

  • Moses H. Cone Memorial Hosp. CRS

    Greensboro, North Carolina, 27401

  • Houston AIDS Research Team CRS (31473)

    Houston, Texas, 77030

  • University of Southern California CRS (1201)

    Los Angeles, California, 90033

  • UCLA CARE Center CRS (601)

    Los Angeles, California, 90095

  • University of Miami AIDS CRS (901)

    Miami, Florida, 33139

  • Vanderbilt Therapeutics CRS (3652)

    Nashville, Tennessee, 37232

  • Cornell CRS (7804)

    New York, New York, 10011

  • HIV Prevention and Treatment

    New York, New York, 10032

  • New Jersey Medical School- Adult Clinical Research Ctr. CRS

    Newark, New Jersey, 07103

  • Stanford

    Palo Alto, California, 94304

  • Hospital of the University of Pennsylvania CRS (6201)

    Philadelphia, Pennsylvania, 19104

  • The Miriam Hospital ACTG CRS (2951)

    Providence, Rhode Island, 02906

  • Virginia Commonwealth Univ. Medical Ctr. CRS (31475)

    Richmond, Virginia, 23219

  • AIDS Care CRS (1108)

    Rochester, New York, 14607

  • University of Rochester ACTG CRS (1101)

    Rochester, New York, 14642

  • Ucsd, Avrc Crs (701)

    San Diego, California, 92103

  • University of California San Francisco AIDS CRS (801)

    San Francisco, California, 94110

  • University of Washington AIDS CRS (1401)

    Seattle, Washington, 98104

  • Washington University CRS (2101)

    St Louis, Missouri, 63110

Other trials in United States

Puerto Rico1 site

  • Puerto Rico-AIDS CRS (5401)

    San Juan, 00931

Other trials in Puerto Rico

About this study

Official title: Oral HPV Shedding and Oral Warts After Initiation of Antiretroviral Therapy

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).

Read the 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
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01029249
Study groupRoleWhat they receive
ACTG A5257 participantsParticipants in this study will also be enrolled in ACTG A5257.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Measured: Measured at Weeks 16 and 24

Secondary outcomes (17)

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

    Measured: Measured at Weeks 16 and 24

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

    Measured: Measured at one of the pre-entry visits

  3. CD4 count change (compared to baseline)

    Measured: Measured at Weeks 4, 16, and 24

  4. Plasma HIV-1 RNA suppression

    Measured: 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

    Measured: Measured at Weeks 16 or 24

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

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

  7. Number of oral sex partners in the last month

    Measured: Measured at baseline and Weeks 24 and 48

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

    Measured: Measured at baseline and Weeks 24 and 48

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

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

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

    Measured: 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)

    Measured: 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

    Measured: 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

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

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

    Measured: 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

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

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

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

  17. Serum total anti-HPV lgG titers

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

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
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01029249
Sponsor's protocol ID
ACTG A5272
Other IDs
1U01AI068636
Status last verified
Dec 2013
First submitted
7 Dec 2009
Last updated
6 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Chaturvedi AK, Engels EA, Anderson WF, Gillison ML. Incidence trends for human papillomavirus-related and -unrelated oral squamous cell carcinomas in the United States. J Clin Oncol. 2008 Feb 1;26(4):612-9. doi: 10.1200/JCO.2007.14.1713.

    PubMed 18235120

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 35 sites in 2 countries.

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 3 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: finished, as of the sponsor's last update on 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Puerto Rico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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?

On the ClinicalTrials.gov record for NCT01029249, which also lists 1 linked publication.

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 6 Dec 2013.

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