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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00006444 |
Purpose
The purpose of this study is to see how often human papillomavirus (HPV) occurs in HIV-infected women who have not taken anti-HIV drugs and to learn whether taking anti-HIV drugs will affect HPV in women.
HIV infection increases the risk of getting HPV infection. Findings suggest that HIV infection as well as a weakened immune system may increase the chances of getting HPV. Aggressive anti-HIV medication has been shown to strengthen the immune system. Researchers want to learn whether anti-HIV drugs affect the HPV virus or decrease the chances of getting HPV. This study is important because it may provide important information to help manage a woman's health and to determine a woman's risk for developing problems with the cervix (outer end of the uterus).
| Condition |
|---|
|
HIV Infections Papilloma |
| Study Type: | Observational |
| Official Title: | Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART |
| Estimated Enrollment: | 160 |
HIV infection is a significant risk factor for human HPV infection and the development of HPV-associated lesions in the female genital tract. Findings suggest that HIV infection and/or HIV-related immunosuppression increases a woman's susceptibility to HPV infection or alters the natural history of preexisting HPV infection. Treatment with HAART has been shown to result in significant increases in CD4+ cell counts and "partial reconstitution" of the immune system. It is not known whether treatment of HIV infection with potent antiretroviral regimens could affect the persistence of HPV infection and progression of cervical dysplasia. This study is important for HIV-infected women because of the implications for gynecologic management and determination of cervical disease risk.
At baseline, Weeks 24 and 48, and then every 48 weeks until study completion, women undergo pelvic examination and cervical specimens collection by the following methods: 1) Sno-strip; 2) cervicovaginal lavage; 3) cervical brush method; and 4) Pap smear. A colposcopy is required for any woman who has an abnormal Pap smear reading unless the abnormal Pap smear is thought to be due to an intercurrent infection. A cervical biopsy is strongly recommended in the event of an abnormal colposcopy. Blood is collected for HPV antibody testing, viral load, and CD4 measures.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Women may be eligible for this study if they:
Exclusion Criteria
Women will not be eligible for this study if they:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| University of California San Francisco | |
| San Francisco, California, United States, 941104206 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| Children's Hosp of Los Angeles/UCLA Med Ctr | |
| Los Angeles, California, United States, 900276016 | |
| Univ of California, San Diego | |
| San Diego, California, United States, 92103 | |
| Stanford Univ | |
| Stanford, California, United States, 94305-5107 | |
| San Mateo County AIDS Program | |
| Stanford, California, United States, 94305-5107 | |
| Willow Clinic | |
| Stanford, California, United States, 94305-5107 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr, Denver | |
| Denver, Colorado, United States, 80262-3706 | |
| United States, District of Columbia | |
| Howard Univ Hosp | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| Univ of Miami (Pediatric) | |
| Miami, Florida, United States, 33161 | |
| Univ of Florida Health Science Ctr / Pediatrics | |
| Jacksonville, Florida, United States, 32209 | |
| Univ of Miami / Jackson Memorial Hosp | |
| Miami, Florida, United States, 33136 | |
| North Broward Hosp District | |
| Fort Lauderdale, Florida, United States, 33311 | |
| United States, Georgia | |
| Emory Univ | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Hawaii | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Mt Sinai Hosp Med Ctr / Dept of Pediatrics | |
| Chicago, Illinois, United States, 60608 | |
| The CORE Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| Methodist Hosp of Indiana / Life Care Clinic | |
| Indianapolis, Indiana, United States, 46202 | |
| Wishard Hosp | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| Univ of Maryland (Pediatric) | |
| Baltimore, Maryland, United States, 20201 | |
| Univ of Maryland, Institute of Human Virology | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Beth Israel Deaconess - West Campus | |
| Boston, Massachusetts, United States, 02215 | |
| Boston Med Ctr (Pediatric) | |
| Boston, Massachusetts, United States, 02118 | |
| Boston Med Ctr (Harvard) | |
| Boston, Massachusetts, United States, 02118 | |
| Brigham and Women's Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 10032 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| State Univ of New York at Stony Brook | |
| Stony Brook, New York, United States, 117948111 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| Montefiore Med Ctr Adolescent AIDS Program | |
| Bronx, New York, United States, 10467 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Community Health Network | |
| Rochester, New York, United States, 14642-001 | |
| United States, North Carolina | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| MetroHealth Med Ctr | |
| Cleveland, Ohio, United States, 441091998 | |
| United States, Pennsylvania | |
| Univ of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Brown Univ / The Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| Miriam Hosp / Brown Univ | |
| Providence, Rhode Island, United States, 02906 | |
| Brown Univ / Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Washington | |
| University of Washington (Seattle) | |
| Seattle, Washington, United States, 98104 | |
| Puerto Rico | |
| San Juan City Hosp | |
| San Juan, Puerto Rico, 009367344 | |
| Univ of Puerto Rico / Univ Children's Hosp AIDS | |
| San Juan, Puerto Rico, 009365067 | |
| Study Chair: | Kathleen Squires | |
| Study Chair: | Rebecca Clark | |
| Study Chair: | Kenneth H Fife |
More Information
| Study ID Numbers: | ACTG A5029, AACTG A5029 |
| Study First Received: | November 3, 2000 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006444 History of Changes |
| Health Authority: | United States: Federal Government |
|
Drug Therapy, Combination Papillomavirus, Human DNA, Viral Anti-HIV Agent Treatment Naive |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Neoplasms by Histologic Type Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes Virus Diseases |
Neoplasms HIV Infections Sexually Transmitted Diseases Lentivirus Infections Neoplasms, Squamous Cell Papilloma Retroviridae Infections Neoplasms, Glandular and Epithelial |
