Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART
13 Years
N/A
Female
HIV Infections, Papilloma
Trial Information
Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART
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.
Inclusion Criteria
Inclusion Criteria
Women may be eligible for this study if they:
- Are HIV-positive.
- Are at least 13 years of age and menstruating.
- Are willing to enroll in another drug study.
- Have written consent of a parent or guardian if under 18 years.
- This study has been changed to increase enrollment. Women who are starting
HAART-based therapy prescribed by a personal physician or participating in an
antiretroviral trial are all eligible.
- Intend to start antiretroviral therapy within 14 days of study entry.
Exclusion Criteria
Women will not be eligible for this study if they:
- Have been on anti-HIV treatment for more than 14 days.
- Are abusing drugs or alcohol.
- Are receiving medication that affects the immune system, fights HPV, or is
investigational, except for anti-HIV drugs provided by coenrolling in a Phase II or
III trial with approval of a study chair within 30 days of study entry, including but
not limited to systemic interferons and interleukins, thalidomide, systemic
cidofovir, and HPV vaccines. This study has been changed. The following medications
are no longer excluded: thymopentin, hydroxyurea, granulocyte colony-stimulating
factor (G-CSF and filgrastim), and GM-CSF (sargramostim).
- Have cervical cancer or a history of cervical cancer.
- Have had a hysterectomy (removal of the uterus).
- Participated in HPV trials at any time.
- Use imiquimod inside the vagina.
- Are taking corticosteroid treatment in large doses.
Type of Study:
Observational
Study Design:
N/A
Principal Investigator
Kathleen Squires
Investigator Role:
Study Chair
Authority:
United States: Federal Government
Study ID:
A5029
NCT ID:
NCT00006444
Start Date:
November 2000
Completion Date:
August 2005
Related Keywords:
- HIV Infections
- Papilloma
- Drug Therapy, Combination
- Papillomavirus, Human
- DNA, Viral
- Anti-HIV Agent
- Treatment Naive
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Papilloma
Name | Location |
|---|---|
| San Mateo County AIDS Program | San Mateo, California 94305 |
| Children's Hosp of Los Angeles/UCLA Med Ctr | Los Angeles, California 900276016 |
| Bellevue Hosp / New York Univ Med Ctr | New York, New York 10016 |
| Univ of Rochester Medical Center | Rochester, New York 14642 |
| Julio Arroyo | West Columbia, South Carolina 29169 |
| Los Angeles County - USC Med Ctr | Los Angeles, California 90033 |
| UCLA CARE Ctr | Los Angeles, California 90095 |
| Univ of Miami School of Medicine | Miami, Florida 331361013 |
| Northwestern Univ Med School | Chicago, Illinois 60611 |
| Indiana Univ Hosp | Indianapolis, Indiana 462025250 |
| Beth Israel Deaconess - West Campus | Boston, Massachusetts 02215 |
| Univ of North Carolina | Chapel Hill, North Carolina 275997215 |
| Duke Univ Med Ctr | Durham, North Carolina 27710 |
| Johns Hopkins Hosp | Baltimore, Maryland 21287 |
| Univ of Alabama at Birmingham | Birmingham, Alabama 35294 |
| Univ of Southern California / LA County USC Med Ctr | Los Angeles, California 900331079 |
| Beth Israel Med Ctr | New York, New York 10003 |
| Univ of Hawaii | Honolulu, Hawaii 96816 |
| Methodist Hosp of Indiana / Life Care Clinic | Indianapolis, Indiana 46202 |
| Montefiore Med Ctr Adolescent AIDS Program | Bronx, New York 10467 |
| Columbia Presbyterian Med Ctr | New York, New York 100323784 |
| MetroHealth Med Ctr | Cleveland, Ohio 441091998 |
| Case Western Reserve Univ | Cleveland, Ohio 44106 |
| Univ of Miami (Pediatric) | Miami, Florida 33161 |
| Emory Univ | Atlanta, Georgia 30308 |
| Willow Clinic | Menlo Park, California 94025 |
| Brigham and Women's Hosp | Boston, Massachusetts 02215 |
| Mt Sinai Hosp Med Ctr / Dept of Pediatrics | Chicago, Illinois 60608 |
| Univ of California, San Diego | San Diego, California 92103 |
| Howard Univ Hosp | Washington, District of Columbia 20060 |
| North Broward Hosp District | Fort Lauderdale, Florida 33311 |
| Univ of Florida Health Science Ctr / Pediatrics | Jacksonville, Florida 32209 |
| State Univ of New York at Stony Brook | Stony Brook, New York 117948111 |
| University of California San Francisco | San Francisco, California 941104206 |
| Stanford Univ | Stanford, California 94305-5107 |
| Univ of Colorado Health Sciences Ctr, Denver | Denver, Colorado 80262-3706 |
| Univ of Miami / Jackson Memorial Hosp | Miami, Florida 33136 |
| The CORE Ctr | Chicago, Illinois 60612 |
| Wishard Hosp | Indianapolis, Indiana 46202 |
| Univ of Maryland (Pediatric) | Baltimore, Maryland 20201 |
| Univ of Maryland, Institute of Human Virology | Baltimore, Maryland 21201 |
| Boston Med Ctr (Harvard) | Boston, Massachusetts 02118 |
| Boston Med Ctr (Pediatric) | Boston, Massachusetts 02118 |
| Community Health Network | Rochester, New York 14642-001 |
| Univ of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| Brown Univ / The Miriam Hosp | Providence, Rhode Island 02906 |
| Miriam Hosp / Brown Univ | Providence, Rhode Island 02906 |
| Brown Univ / Miriam Hosp | Providence, Rhode Island 02906 |
| University of Washington (Seattle) | Seattle, Washington 98104 |
