Sponsor study identifier
Secondary identifiers
NIH
observational
500
2 countries
35
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 7, 2009
Actual (reported)December 9, 2009
Actual (reported)January 2010
Date type not reportedThis date has not been verified as actual or estimated.
May 2013
Actual (reported)May 2013
Actual (reported)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
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
Participants in this study will also be enrolled in ACTG A5257.
Participants in this study will also be enrolled in ACTG A5257.
Alabama Therapeutics CRS (5801)
Birmingham, Alabama, 35294-2050, United States
University of Southern California CRS (1201)
Los Angeles, California, 90033, United States
UCLA CARE Center CRS (601)
Los Angeles, California, 90095, United States
Stanford
Palo Alto, California, 94304, United States
Ucsd, Avrc Crs (701)
San Diego, California, 92103, United States
University of California San Francisco AIDS CRS (801)
San Francisco, California, 94110, United States
University of Miami AIDS CRS (901)
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.
Saliva and blood will be collected from participants.
Caroline Shiboski, DDS, MPH, PhD
Department of Orofacial Sciences, UCSF AIDS OHARA
Mark A. Jacobson, MD
UCSF AIDS OHARA, Positive Health Program, San Francisco General Hospital
500 participants (actual enrollment reported by the registry).
First Submitted
December 7, 2009
First Posted
December 9, 2009
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Chloroquine for Reducing Immune Activation in HIV- Infected Individuals
Contact the study team to confirm eligibility.
Miami, Florida, 33139, United States
The Ponce de Leon Ctr. CRS (5802)
Atlanta, Georgia, 30308, United States
Northwestern University CRS (2701)
Chicago, Illinois, 60611, United States
Rush University Medical Center (2702)
Chicago, Illinois, 60612, United States
IHV Baltimore Treatment CRS (4651)
Baltimore, Maryland, 21201, United States
Beth Israel Deaconess Medical Center ACTG CRS (103)
Boston, Maryland, 02215, United States
Massachusetts General Hospital ACTG CRS (101)
Boston, Massachusetts, 02114, United States
Henry Ford Hosp. CRS (31472)
Detroit, Michigan, 48202, United States
Washington University CRS (2101)
St Louis, Missouri, 63110, United States
Cooper Univ. Hosp. CRS (31476)
Camden, New Jersey, 08103, United States
New Jersey Medical School- Adult Clinical Research Ctr. CRS
Newark, New Jersey, 07103, United States
Cornell CRS (7804)
New York, New York, 10011, United States
HIV Prevention and Treatment
New York, New York, 10032, United States
AIDS Care CRS (1108)
Rochester, New York, 14607, United States
University of Rochester ACTG CRS (1101)
Rochester, New York, 14642, United States
University of North Carolina AIDS CRS
Chapel Hill, North Carolina, 27514, United States
Duke Univ. Med. Ctr. Adult CRS (1601)
Durham, North Carolina, 27710, United States
Moses H. Cone Memorial Hosp. CRS
Greensboro, North Carolina, 27401, United States
University of Cincinnati CRS
Cincinnati, Ohio, 45267, United States
Case CRS (2501)
Cleveland, Ohio, 44106, United States
MetroHealth CRS (2503)
Cleveland, Ohio, 44109, United States
The Ohio State University AIDS CRS (2301)
Colombus, Ohio, 43210, United States
Hospital of the University of Pennsylvania CRS (6201)
Philadelphia, Pennsylvania, 19104, United States
The Miriam Hospital ACTG CRS (2951)
Providence, Rhode Island, 02906, United States
Vanderbilt Therapeutics CRS (3652)
Nashville, Tennessee, 37232, United States
Houston AIDS Research Team CRS (31473)
Houston, Texas, 77030, United States
Virginia Commonwealth Univ. Medical Ctr. CRS (31475)
Richmond, Virginia, 23219, United States
University of Washington AIDS CRS (1401)
Seattle, Washington, 98104, United States
Puerto Rico-AIDS CRS (5401)
San Juan, 00931, Puerto Rico
Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)Last Updated
December 6, 2013
Record last verified: 2013-12
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Source: ClinicalTrials.gov.
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