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Home > "T" Clinical Trials Conditions > The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women  The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
For Condition: HIV Infections,Papilloma
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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).
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Female
Protocol Entry 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.
Total Enrollment: 160
Location and Contact Information:
Overall Study Official:
KathleenSquires, Study Chair,
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
United States
Wishard Hosp
Indianapolis, Indiana, 46202
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
The CORE Ctr
Chicago, Illinois, 60612
United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906
United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Boston Med Ctr (Pediatric)
Boston, Massachusetts, 02118
United States
Univ of Colorado Health Sciences Ctr, Denver
Denver, Colorado, 80262-3706
United States
Boston Med Ctr (Harvard)
Boston, Massachusetts, 02118
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02215
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Willow Clinic
Stanford, California, 94305-5107
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Maryland (Pediatric)
Baltimore, Maryland, 20201
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Stanford Univ
Stanford, California, 94305-5107
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Univ of California, San Diego
San Diego, California, 92103
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Community Health Network
Rochester, New York, 14642-001
United States
Brown Univ / The Miriam Hosp
Providence, Rhode Island, 02906
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
United States
University of Washington (Seattle)
Seattle, Washington, 98104
United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
University of California San Francisco
San Francisco, California, 941104206
United States
San Mateo County AIDS Program
Stanford, California, 94305-5107
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Additional Information:
Study ID Numbers: ACTG A5029; AACTG A5029
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006444
Other Papilloma Studies:
1. The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
2. A Trial Study of SGN-00101 in Treating Pediatric Patients with Recurrent Respiratory Papillomatosis
3. Treatment with Cidofovir for Children with Laryngeal Papillomatosis (Warts in the Throat)
4. The Effects of Upper Airway and Digestive Tract Tumors on the Immune System
Related Studies:
Other Papilloma Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
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