- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00006444
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
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).
연구 개요
상세 설명
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.
연구 유형
등록
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- Univ of Alabama at Birmingham
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California
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Los Angeles, California, 미국, 90095
- UCLA CARE Ctr
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Los Angeles, California, 미국, 900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
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Los Angeles, California, 미국, 90033
- Los Angeles County - USC Med Ctr
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Los Angeles, California, 미국, 900331079
- Univ of Southern California / LA County USC Med Ctr
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San Diego, California, 미국, 92103
- Univ of California, San Diego
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San Francisco, California, 미국, 941104206
- University of California San Francisco
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Stanford, California, 미국, 94305-5107
- San Mateo County AIDS Program
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Stanford, California, 미국, 94305-5107
- Stanford Univ
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Stanford, California, 미국, 94305-5107
- Willow Clinic
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Colorado
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Denver, Colorado, 미국, 80262-3706
- Univ of Colorado Health Sciences Ctr, Denver
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District of Columbia
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Washington, District of Columbia, 미국, 20060
- Howard Univ Hosp
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Florida
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Fort Lauderdale, Florida, 미국, 33311
- North Broward Hosp District
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Jacksonville, Florida, 미국, 32209
- Univ of Florida Health Science Ctr / Pediatrics
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Miami, Florida, 미국, 331361013
- Univ of Miami School of Medicine
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Miami, Florida, 미국, 33161
- Univ of Miami (Pediatric)
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Miami, Florida, 미국, 33136
- Univ of Miami / Jackson Memorial Hosp
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Georgia
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Atlanta, Georgia, 미국, 30308
- Emory Univ
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Hawaii
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Honolulu, Hawaii, 미국, 96816
- Univ of Hawaii
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Illinois
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Chicago, Illinois, 미국, 60612
- The CORE Ctr
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Chicago, Illinois, 미국, 60611
- Northwestern Univ Med School
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Chicago, Illinois, 미국, 60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
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Indiana
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Indianapolis, Indiana, 미국, 462025250
- Indiana Univ Hosp
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Indianapolis, Indiana, 미국, 46202
- Methodist Hosp of Indiana / Life Care Clinic
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Indianapolis, Indiana, 미국, 46202
- Wishard Hosp
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Maryland
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Baltimore, Maryland, 미국, 21287
- Johns Hopkins Hosp
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Baltimore, Maryland, 미국, 21201
- Univ of Maryland, Institute of Human Virology
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Baltimore, Maryland, 미국, 20201
- Univ of Maryland (Pediatric)
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess - West Campus
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Boston, Massachusetts, 미국, 02215
- Brigham and Women's Hosp
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Boston, Massachusetts, 미국, 02118
- Boston Med Ctr (Pediatric)
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Boston, Massachusetts, 미국, 02118
- Boston Med Ctr (Harvard)
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New York
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Bronx, New York, 미국, 10467
- Montefiore Med Ctr Adolescent AIDS Program
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New York, New York, 미국, 10003
- Beth Israel Med Ctr
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New York, New York, 미국, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, 미국, 10032
- Columbia Presbyterian Med Ctr
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Rochester, New York, 미국, 14642
- Univ of Rochester Medical Center
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Rochester, New York, 미국, 14642-001
- Community Health Network
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Stony Brook, New York, 미국, 117948111
- State Univ of New York at Stony Brook
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North Carolina
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Chapel Hill, North Carolina, 미국, 275997215
- Univ of North Carolina
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Durham, North Carolina, 미국, 27710
- Duke Univ Med Ctr
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Ohio
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Cleveland, Ohio, 미국, 44106
- Case Western Reserve Univ
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Cleveland, Ohio, 미국, 441091998
- MetroHealth Med Ctr
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- Univ of Pittsburgh
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Rhode Island
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Providence, Rhode Island, 미국, 02906
- Brown Univ / Miriam Hosp
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Providence, Rhode Island, 미국, 02906
- Miriam Hosp / Brown Univ
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Providence, Rhode Island, 미국, 02906
- Brown Univ / The Miriam Hosp
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South Carolina
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West Columbia, South Carolina, 미국, 29169
- Julio Arroyo
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Washington
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Seattle, Washington, 미국, 98104
- University of Washington (Seattle)
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San Juan, 푸에르토 리코, 009367344
- San Juan City Hosp
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San Juan, 푸에르토 리코, 009365067
- Univ of Puerto Rico / Univ Children's Hosp AIDS
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
공동 작업자 및 조사자
수사관
- 연구 의자: Kathleen Squires
- 연구 의자: Rebecca Clark
- 연구 의자: Kenneth H Fife
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- A5029
- AACTG A5029
- ACTG A5029
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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