The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
NCT ID: NCT00006444
Last Updated: 2013-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
160 participants
OBSERVATIONAL
2000-11-30
2005-08-31
Brief Summary
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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).
Detailed Description
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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.
Conditions
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Keywords
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
13 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Kathleen Squires
Role: STUDY_CHAIR
Rebecca Clark
Role: STUDY_CHAIR
Kenneth H Fife
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCLA CARE Ctr
Los Angeles, California, United States
Univ of California, San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
San Mateo County AIDS Program
Stanford, California, United States
Stanford Univ
Stanford, California, United States
Willow Clinic
Stanford, California, United States
Univ of Colorado Health Sciences Ctr, Denver
Denver, Colorado, United States
Howard Univ Hosp
Washington D.C., District of Columbia, United States
North Broward Hosp District
Fort Lauderdale, Florida, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Emory Univ
Atlanta, Georgia, United States
Univ of Hawaii
Honolulu, Hawaii, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, United States
Northwestern Univ Med School
Chicago, Illinois, United States
The CORE Ctr
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States
Wishard Hosp
Indianapolis, Indiana, United States
Univ of Maryland (Pediatric)
Baltimore, Maryland, United States
Univ of Maryland, Institute of Human Virology
Baltimore, Maryland, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Boston Med Ctr (Harvard)
Boston, Massachusetts, United States
Boston Med Ctr (Pediatric)
Boston, Massachusetts, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States
Brigham and Women's Hosp
Boston, Massachusetts, United States
Beth Israel Med Ctr
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Community Health Network
Rochester, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
State Univ of New York at Stony Brook
Stony Brook, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Case Western Reserve Univ
Cleveland, Ohio, United States
MetroHealth Med Ctr
Cleveland, Ohio, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, United States
Brown Univ / The Miriam Hosp
Providence, Rhode Island, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, United States
Julio Arroyo
West Columbia, South Carolina, United States
University of Washington (Seattle)
Seattle, Washington, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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Other Identifiers
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AACTG A5029
Identifier Type: -
Identifier Source: secondary_id
ACTG A5029
Identifier Type: -
Identifier Source: secondary_id
A5029
Identifier Type: -
Identifier Source: org_study_id