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

November 19, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Study Chair: Kathleen Squires
  • Study Chair: Rebecca Clark
  • Study Chair: Kenneth H Fife

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

November 3, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

November 20, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5029
  • AACTG A5029
  • ACTG A5029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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