- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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).
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning
Kontakter och platser
Studieorter
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 35294
- Univ of Alabama at Birmingham
-
-
California
-
Los Angeles, California, Förenta staterna, 90095
- UCLA CARE Ctr
-
Los Angeles, California, Förenta staterna, 900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
-
Los Angeles, California, Förenta staterna, 90033
- Los Angeles County - USC Med Ctr
-
Los Angeles, California, Förenta staterna, 900331079
- Univ of Southern California / LA County USC Med Ctr
-
San Diego, California, Förenta staterna, 92103
- Univ of California, San Diego
-
San Francisco, California, Förenta staterna, 941104206
- University of California San Francisco
-
Stanford, California, Förenta staterna, 94305-5107
- San Mateo County AIDS Program
-
Stanford, California, Förenta staterna, 94305-5107
- Stanford Univ
-
Stanford, California, Förenta staterna, 94305-5107
- Willow Clinic
-
-
Colorado
-
Denver, Colorado, Förenta staterna, 80262-3706
- Univ of Colorado Health Sciences Ctr, Denver
-
-
District of Columbia
-
Washington, District of Columbia, Förenta staterna, 20060
- Howard Univ Hosp
-
-
Florida
-
Fort Lauderdale, Florida, Förenta staterna, 33311
- North Broward Hosp District
-
Jacksonville, Florida, Förenta staterna, 32209
- Univ of Florida Health Science Ctr / Pediatrics
-
Miami, Florida, Förenta staterna, 331361013
- Univ of Miami School of Medicine
-
Miami, Florida, Förenta staterna, 33161
- Univ of Miami (Pediatric)
-
Miami, Florida, Förenta staterna, 33136
- Univ of Miami / Jackson Memorial Hosp
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30308
- Emory Univ
-
-
Hawaii
-
Honolulu, Hawaii, Förenta staterna, 96816
- Univ of Hawaii
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60612
- The CORE Ctr
-
Chicago, Illinois, Förenta staterna, 60611
- Northwestern Univ Med School
-
Chicago, Illinois, Förenta staterna, 60608
- Mt Sinai Hosp Med Ctr / Dept of Pediatrics
-
-
Indiana
-
Indianapolis, Indiana, Förenta staterna, 462025250
- Indiana Univ Hosp
-
Indianapolis, Indiana, Förenta staterna, 46202
- Methodist Hosp of Indiana / Life Care Clinic
-
Indianapolis, Indiana, Förenta staterna, 46202
- Wishard Hosp
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins Hosp
-
Baltimore, Maryland, Förenta staterna, 21201
- Univ of Maryland, Institute of Human Virology
-
Baltimore, Maryland, Förenta staterna, 20201
- Univ of Maryland (Pediatric)
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02215
- Beth Israel Deaconess - West Campus
-
Boston, Massachusetts, Förenta staterna, 02215
- Brigham and Women's Hosp
-
Boston, Massachusetts, Förenta staterna, 02118
- Boston Med Ctr (Pediatric)
-
Boston, Massachusetts, Förenta staterna, 02118
- Boston Med Ctr (Harvard)
-
-
New York
-
Bronx, New York, Förenta staterna, 10467
- Montefiore Med Ctr Adolescent AIDS Program
-
New York, New York, Förenta staterna, 10003
- Beth Israel Med Ctr
-
New York, New York, Förenta staterna, 10016
- Bellevue Hosp / New York Univ Med Ctr
-
New York, New York, Förenta staterna, 10032
- Columbia Presbyterian Med Ctr
-
Rochester, New York, Förenta staterna, 14642
- Univ of Rochester Medical Center
-
Rochester, New York, Förenta staterna, 14642-001
- Community Health Network
-
Stony Brook, New York, Förenta staterna, 117948111
- State Univ of New York at Stony Brook
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 275997215
- Univ of North Carolina
-
Durham, North Carolina, Förenta staterna, 27710
- Duke Univ Med Ctr
-
-
Ohio
-
Cleveland, Ohio, Förenta staterna, 44106
- Case Western Reserve Univ
-
Cleveland, Ohio, Förenta staterna, 441091998
- MetroHealth Med Ctr
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213
- Univ of Pittsburgh
-
-
Rhode Island
-
Providence, Rhode Island, Förenta staterna, 02906
- Brown Univ / Miriam Hosp
-
Providence, Rhode Island, Förenta staterna, 02906
- Miriam Hosp / Brown Univ
-
Providence, Rhode Island, Förenta staterna, 02906
- Brown Univ / The Miriam Hosp
-
-
South Carolina
-
West Columbia, South Carolina, Förenta staterna, 29169
- Julio Arroyo
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98104
- University of Washington (Seattle)
-
-
-
-
-
San Juan, Puerto Rico, 009367344
- San Juan City Hosp
-
San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico / Univ Children's Hosp AIDS
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Kathleen Squires
- Studiestol: Rebecca Clark
- Studiestol: Kenneth H Fife
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- A5029
- AACTG A5029
- ACTG A5029
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på HIV-infektioner
-
Institut PasteurRekrytering
-
Duke UniversityAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Förenta staterna
-
Catholic University of the Sacred HeartAvslutadCentral Line-associated Bloodstream Infection (CLABSI)
-
The University of Texas Health Science Center,...EurofinsAvslutadOdontogen Deep Space Neck InfectionFörenta staterna
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekryteringCentral Line-associated Bloodstream Infection (CLABSI)Nederländerna
-
University of MalayaTeleflexRekryteringCLABSI - Central Line Associated Bloodstream InfectionMalaysia
-
Johns Hopkins UniversityAvslutadCLABSI - Central Line Associated Bloodstream InfectionFörenta staterna
-
National Taiwan University HospitalAvslutadCentral Line-associated Bloodstream Infection (CLABSI)Taiwan
-
National Taiwan University Hospital Hsin-Chu BranchAvslutadCentral Line-associated Bloodstream Infection (CLABSI)
-
Port Said UniversityRekryteringCentral Line-associated Bloodstream Infection (CLABSI)Egypten