Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI068636 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTG A5257 participants | Participants in this study will also be enrolled in ACTG A5257. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants in this study will also be enrolled in ACTG A5257.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Therapeutics CRS (5801) | Birmingham | Alabama | 35294-2050 | United States | ||
| University of Southern California CRS (1201) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18235120 | Background | 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. |
| Label | URL |
|---|---|
| Click here for the ACTG A5257 ClinicalTrials.gov study record. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Saliva and blood will be collected from participants.
| 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 |
| Clinical diagnosis (presence versus absence) or oral warts measured by a visual exam | Measured at baseline and Weeks 16, 24, and 48 |
| Number of oral sex partners in the last month | Measured at baseline and Weeks 24 and 48 |
| Number of oral sex partners in the last 6 months | Measured at baseline and Weeks 24 and 48 |
| Absolute CD8 count (obtained from A5257 study data) | Measured at Weeks 0 and 24 in the A5257 study |
| Absolute CD4 count (obtained from A5257 study data) | Measured at Weeks 0, 24, and 48 in the A5257 study |
| 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 during the A5272 study or obtained from stored specimens |
| 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 during the A5272 study or obtained from stored specimens |
| Percentage and absolute number of CD4 cells that are regulatory T cells (CD4+/CD25+/CD127low) measured from PBMCs | Measured during the A5272 study or obtained from stored specimens |
| Percentage of CD4 cells and CD8 cells that express CD38 and HLA-DR | Measured during the A5272 study or obtained from stored specimens |
| Persistence of HPV DNA of a specific type in throat wash specimens over the time course of the study | Measured during the A5272 study or obtained from stored specimens |
| Salivary total lgA and anti-HPV lgA and S-lgA titers | Measured during the A5272 study or obtained from stored specimens |
| Serum total anti-HPV lgG titers | Measured during the A5272 study or obtained from stored specimens |
| 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) | 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 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided