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Spots Global Cancer Trial Database for The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women

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Trial Identification

Brief Title: The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women

Official Title: Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART

Study ID: NCT00006444

Interventions

Study Description

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.

Eligibility

Minimum Age: 13 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Univ of Alabama at Birmingham, Birmingham, Alabama, United States

Children's Hosp of Los Angeles/UCLA Med Ctr, Los Angeles, California, United States

Univ of Southern California / LA County USC Med Ctr, Los Angeles, California, United States

Los Angeles County - USC Med Ctr, Los Angeles, California, United States

UCLA CARE Ctr, Los Angeles, California, United States

Univ of California, San Diego, San Diego, California, United States

University of California San Francisco, San Francisco, California, United States

San Mateo County AIDS Program, Stanford, California, United States

Stanford Univ, Stanford, California, United States

Willow Clinic, Stanford, California, United States

Univ of Colorado Health Sciences Ctr, Denver, Denver, Colorado, United States

Howard Univ Hosp, Washington, District of Columbia, United States

North Broward Hosp District, Fort Lauderdale, Florida, United States

Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida, United States

Univ of Miami School of Medicine, Miami, Florida, United States

Univ of Miami / Jackson Memorial Hosp, Miami, Florida, United States

Univ of Miami (Pediatric), Miami, Florida, United States

Emory Univ, Atlanta, Georgia, United States

Univ of Hawaii, Honolulu, Hawaii, United States

Mt Sinai Hosp Med Ctr / Dept of Pediatrics, Chicago, Illinois, United States

Northwestern Univ Med School, Chicago, Illinois, United States

The CORE Ctr, Chicago, Illinois, United States

Indiana Univ Hosp, Indianapolis, Indiana, United States

Methodist Hosp of Indiana / Life Care Clinic, Indianapolis, Indiana, United States

Wishard Hosp, Indianapolis, Indiana, United States

Univ of Maryland (Pediatric), Baltimore, Maryland, United States

Univ of Maryland, Institute of Human Virology, Baltimore, Maryland, United States

Johns Hopkins Hosp, Baltimore, Maryland, United States

Boston Med Ctr (Harvard), Boston, Massachusetts, United States

Boston Med Ctr (Pediatric), Boston, Massachusetts, United States

Beth Israel Deaconess - West Campus, Boston, Massachusetts, United States

Brigham and Women's Hosp, Boston, Massachusetts, United States

Montefiore Med Ctr Adolescent AIDS Program, Bronx, New York, United States

Beth Israel Med Ctr, New York, New York, United States

Bellevue Hosp / New York Univ Med Ctr, New York, New York, United States

Columbia Presbyterian Med Ctr, New York, New York, United States

Community Health Network, Rochester, New York, United States

Univ of Rochester Medical Center, Rochester, New York, United States

State Univ of New York at Stony Brook, Stony Brook, New York, United States

Univ of North Carolina, Chapel Hill, North Carolina, United States

Duke Univ Med Ctr, Durham, North Carolina, United States

Case Western Reserve Univ, Cleveland, Ohio, United States

MetroHealth Med Ctr, Cleveland, Ohio, United States

Univ of Pittsburgh, Pittsburgh, Pennsylvania, United States

Brown Univ / Miriam Hosp, Providence, Rhode Island, United States

Brown Univ / The Miriam Hosp, Providence, Rhode Island, United States

Miriam Hosp / Brown Univ, Providence, Rhode Island, United States

Julio Arroyo, West Columbia, South Carolina, United States

University of Washington (Seattle), Seattle, Washington, United States

Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan, , Puerto Rico

San Juan City Hosp, San Juan, , Puerto Rico

Contact Details

Name: Kathleen Squires

Affiliation:

Role: STUDY_CHAIR

Name: Rebecca Clark

Affiliation:

Role: STUDY_CHAIR

Name: Kenneth H Fife

Affiliation:

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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