The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
- Conditions
- HIV InfectionsPapilloma
- Registration Number
- NCT00006444
- 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 160
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
Univ of Maryland (Pediatric)
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hosp
🇺🇸Boston, Massachusetts, United States
State Univ of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
Univ of California, San Diego
🇺🇸San Diego, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Wishard Hosp
🇺🇸Indianapolis, Indiana, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
San Mateo County AIDS Program
🇺🇸Stanford, California, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
🇺🇸Los Angeles, California, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
The CORE Ctr
🇺🇸Chicago, Illinois, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Stanford Univ
🇺🇸Stanford, California, United States
Willow Clinic
🇺🇸Stanford, California, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Boston Med Ctr (Harvard)
🇺🇸Boston, Massachusetts, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic
🇺🇸Indianapolis, Indiana, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
Univ of Florida Health Science Ctr / Pediatrics
🇺🇸Jacksonville, Florida, United States
Univ of Maryland, Institute of Human Virology
🇺🇸Baltimore, Maryland, United States
Brown Univ / The Miriam Hosp
🇺🇸Providence, Rhode Island, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
MetroHealth Med Ctr
🇺🇸Cleveland, Ohio, United States
Brown Univ / Miriam Hosp
🇺🇸Providence, Rhode Island, United States
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Miriam Hosp / Brown Univ
🇺🇸Providence, Rhode Island, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Univ of Colorado Health Sciences Ctr, Denver
🇺🇸Denver, Colorado, United States
Community Health Network
🇺🇸Rochester, New York, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Boston Med Ctr (Pediatric)
🇺🇸Boston, Massachusetts, United States
Univ of Miami / Jackson Memorial Hosp
🇺🇸Miami, Florida, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
🇺🇸Chicago, Illinois, United States
Montefiore Med Ctr Adolescent AIDS Program
🇺🇸Bronx, New York, United States
University of Washington (Seattle)
🇺🇸Seattle, Washington, United States
Univ of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States