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

NCT01029249 | Completed DMC

• 2 other identifiers: ACTG A52721U01AI068636
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 35

Brief 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).

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

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

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

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

  Measured at Weeks 16 and 24

Secondary Outcomes (17)

• Clinical diagnosis (presence versus absence) of oral warts

  Measured at Weeks 16 and 24

• HPV shedding at one of the pre-HAART visits

  Measured at one of the pre-entry visits

• CD4 count change (compared to baseline)

  Measured at Weeks 4, 16, and 24

• Plasma HIV-1 RNA suppression

  Measured at Weeks 4, 16, and 24

• 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 at Weeks 16 or 24

Study Arms (1)

ACTG A5257 participants

Participants in this study will also be enrolled in ACTG A5257.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in this study will also be enrolled in ACTG A5257.

You may qualify if:

• Ability and willingness of participant or legal guardian/representative to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (35)

Alabama Therapeutics CRS (5801)

Birmingham, Alabama, 35294-2050, United States

Location

University of Southern California CRS (1201)

Los Angeles, California, 90033, United States

Location

UCLA CARE Center CRS (601)

Los Angeles, California, 90095, United States

Location

Stanford

Palo Alto, California, 94304, United States

Location

Ucsd, Avrc Crs (701)

San Diego, California, 92103, United States

Location

University of California San Francisco AIDS CRS (801)

San Francisco, California, 94110, United States

Location

University of Miami AIDS CRS (901)

Miami, Florida, 33139, United States

Location

The Ponce de Leon Ctr. CRS (5802)

Atlanta, Georgia, 30308, United States

Location

Northwestern University CRS (2701)

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center (2702)

Chicago, Illinois, 60612, United States

Location

IHV Baltimore Treatment CRS (4651)

Baltimore, Maryland, 21201, United States

Location

Beth Israel Deaconess Medical Center ACTG CRS (103)

Boston, Maryland, 02215, United States

Location

Massachusetts General Hospital ACTG CRS (101)

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hosp. CRS (31472)

Detroit, Michigan, 48202, United States

Location

Washington University CRS (2101)

St Louis, Missouri, 63110, United States

Location

Cooper Univ. Hosp. CRS (31476)

Camden, New Jersey, 08103, United States

Location

New Jersey Medical School- Adult Clinical Research Ctr. CRS

Newark, New Jersey, 07103, United States

Location

Cornell CRS (7804)

New York, New York, 10011, United States

Location

HIV Prevention and Treatment

New York, New York, 10032, United States

Location

AIDS Care CRS (1108)

Rochester, New York, 14607, United States

Location

University of Rochester ACTG CRS (1101)

Rochester, New York, 14642, United States

Location

University of North Carolina AIDS CRS

Chapel Hill, North Carolina, 27514, United States

Location

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

Durham, North Carolina, 27710, United States

Location

Moses H. Cone Memorial Hosp. CRS

Greensboro, North Carolina, 27401, United States

Location

University of Cincinnati CRS

Cincinnati, Ohio, 45267, United States

Location

Case CRS (2501)

Cleveland, Ohio, 44106, United States

Location

MetroHealth CRS (2503)

Cleveland, Ohio, 44109, United States

Location

The Ohio State University AIDS CRS (2301)

Colombus, Ohio, 43210, United States

Location

Hospital of the University of Pennsylvania CRS (6201)

Philadelphia, Pennsylvania, 19104, United States

Location

The Miriam Hospital ACTG CRS (2951)

Providence, Rhode Island, 02906, United States

Location

Vanderbilt Therapeutics CRS (3652)

Nashville, Tennessee, 37232, United States

Location

Houston AIDS Research Team CRS (31473)

Houston, Texas, 77030, United States

Location

Virginia Commonwealth Univ. Medical Ctr. CRS (31475)

Richmond, Virginia, 23219, United States

Location

University of Washington AIDS CRS (1401)

Seattle, Washington, 98104, United States

Location

Puerto Rico-AIDS CRS (5401)

San Juan, 00931, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 18235120 BACKGROUND

Related Links

• Click here for the ACTG A5257 ClinicalTrials.gov study record.

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and blood will be collected from participants.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Caroline Shiboski, DDS, MPH, PhD

  Department of Orofacial Sciences, UCSF AIDS OHARA

  STUDY CHAIR

• Mark A. Jacobson, MD

  UCSF AIDS OHARA, Positive Health Program, San Francisco General Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: January 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 6, 2013

Record last verified: 2013-12

Locations

PR (1); US (34)