The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART
3 other identifiers
observational
160
2 countries
51
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2000
Longer than P75 for all trials
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2000
CompletedFirst Submitted
Initial submission to the registry
November 3, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedNovember 20, 2013
November 1, 2013
November 3, 2000
November 19, 2013
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Univ of California, San Diego
San Diego, California, 92103, United States
University of California San Francisco
San Francisco, California, 941104206, United States
San Mateo County AIDS Program
Stanford, California, 94305-5107, United States
Stanford Univ
Stanford, California, 94305-5107, United States
Willow Clinic
Stanford, California, 94305-5107, United States
Univ of Colorado Health Sciences Ctr, Denver
Denver, Colorado, 80262-3706, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060, United States
North Broward Hosp District
Fort Lauderdale, Florida, 33311, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Wishard Hosp
Indianapolis, Indiana, 46202, United States
Univ of Maryland (Pediatric)
Baltimore, Maryland, 20201, United States
Univ of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Boston Med Ctr (Harvard)
Boston, Massachusetts, 02118, United States
Boston Med Ctr (Pediatric)
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Community Health Network
Rochester, New York, 14642-001, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906, United States
Brown Univ / The Miriam Hosp
Providence, Rhode Island, 02906, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
University of Washington (Seattle)
Seattle, Washington, 98104, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067, Puerto Rico
San Juan City Hosp
San Juan, 009367344, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kathleen Squires
- STUDY CHAIR
Rebecca Clark
- STUDY CHAIR
Kenneth H Fife