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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006444
First received: November 3, 2000
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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).


Condition
HIV Infections
Papilloma

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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 160
Study Start Date: November 2000
Study Completion Date: August 2005
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006444

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States, 900276016
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Univ of California, San Diego
San Diego, California, United States, 92103
University of California San Francisco
San Francisco, California, United States, 941104206
Willow Clinic
Stanford, California, United States, 94305-5107
San Mateo County AIDS Program
Stanford, California, United States, 94305-5107
Stanford Univ
Stanford, California, United States, 94305-5107
United States, Colorado
Univ of Colorado Health Sciences Ctr, Denver
Denver, Colorado, United States, 80262-3706
United States, District of Columbia
Howard Univ Hosp
Washington, District of Columbia, United States, 20060
United States, Florida
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33311
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States, 33136
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Georgia
Emory Univ
Atlanta, Georgia, United States, 30308
United States, Hawaii
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, United States, 60608
The CORE Ctr
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
Wishard Hosp
Indianapolis, Indiana, United States, 46202
United States, Maryland
Univ of Maryland (Pediatric)
Baltimore, Maryland, United States, 20201
Univ of Maryland, Institute of Human Virology
Baltimore, Maryland, United States, 21201
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Med Ctr (Pediatric)
Boston, Massachusetts, United States, 02118
Brigham and Women's Hosp
Boston, Massachusetts, United States, 02215
Boston Med Ctr (Harvard)
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
United States, New York
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, United States, 10467
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Beth Israel Med Ctr
New York, New York, United States, 10003
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Community Health Network
Rochester, New York, United States, 14642-001
State Univ of New York at Stony Brook
Stony Brook, New York, United States, 117948111
United States, North Carolina
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
United States, Ohio
MetroHealth Med Ctr
Cleveland, Ohio, United States, 441091998
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown Univ / Miriam Hosp
Providence, Rhode Island, United States, 02906
Brown Univ / The Miriam Hosp
Providence, Rhode Island, United States, 02906
Miriam Hosp / Brown Univ
Providence, Rhode Island, United States, 02906
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Washington
University of Washington (Seattle)
Seattle, Washington, United States, 98104
Puerto Rico
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
Sponsors and Collaborators
Investigators
Study Chair: Kathleen Squires
Study Chair: Rebecca Clark
Study Chair: Kenneth H Fife
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006444     History of Changes
Other Study ID Numbers: A5029, AACTG A5029, ACTG A5029
Study First Received: November 3, 2000
Last Updated: November 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
Papillomavirus, Human
DNA, Viral
Anti-HIV Agent
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 16, 2014