search
Back to results

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

Primary Purpose

HIV Infections, Papilloma

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring Drug Therapy, Combination, Papillomavirus, Human, DNA, Viral, Anti-HIV Agent, Treatment Naive

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Children's Hosp of Los Angeles/UCLA Med Ctr
  • Univ of Southern California / LA County USC Med Ctr
  • Los Angeles County - USC Med Ctr
  • UCLA CARE Ctr
  • Univ of California, San Diego
  • University of California San Francisco
  • San Mateo County AIDS Program
  • Stanford Univ
  • Willow Clinic
  • Univ of Colorado Health Sciences Ctr, Denver
  • Howard Univ Hosp
  • North Broward Hosp District
  • Univ of Florida Health Science Ctr / Pediatrics
  • Univ of Miami School of Medicine
  • Univ of Miami / Jackson Memorial Hosp
  • Univ of Miami (Pediatric)
  • Emory Univ
  • Univ of Hawaii
  • Mt Sinai Hosp Med Ctr / Dept of Pediatrics
  • Northwestern Univ Med School
  • The CORE Ctr
  • Indiana Univ Hosp
  • Methodist Hosp of Indiana / Life Care Clinic
  • Wishard Hosp
  • Univ of Maryland (Pediatric)
  • Univ of Maryland, Institute of Human Virology
  • Johns Hopkins Hosp
  • Boston Med Ctr (Harvard)
  • Boston Med Ctr (Pediatric)
  • Beth Israel Deaconess - West Campus
  • Brigham and Women's Hosp
  • Montefiore Med Ctr Adolescent AIDS Program
  • Beth Israel Med Ctr
  • Bellevue Hosp / New York Univ Med Ctr
  • Columbia Presbyterian Med Ctr
  • Community Health Network
  • Univ of Rochester Medical Center
  • State Univ of New York at Stony Brook
  • Univ of North Carolina
  • Duke Univ Med Ctr
  • Case Western Reserve Univ
  • MetroHealth Med Ctr
  • Univ of Pittsburgh
  • Brown Univ / Miriam Hosp
  • Brown Univ / The Miriam Hosp
  • Miriam Hosp / Brown Univ
  • Julio Arroyo
  • University of Washington (Seattle)
  • Univ of Puerto Rico / Univ Children's Hosp AIDS
  • San Juan City Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 2000
Last Updated
November 19, 2013
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT00006444
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 Type
Observational

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Papilloma
Keywords
Drug Therapy, Combination, Papillomavirus, Human, DNA, Viral, Anti-HIV Agent, Treatment Naive

7. Study Design

Enrollment
160 (false)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Squires
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rebecca Clark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kenneth H Fife
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Children's Hosp of Los Angeles/UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900276016
Country
United States
Facility Name
Univ of Southern California / LA County USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900331079
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Univ of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
941104206
Country
United States
Facility Name
San Mateo County AIDS Program
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5107
Country
United States
Facility Name
Stanford Univ
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5107
Country
United States
Facility Name
Willow Clinic
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5107
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr, Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262-3706
Country
United States
Facility Name
Howard Univ Hosp
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
North Broward Hosp District
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Univ of Florida Health Science Ctr / Pediatrics
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
Univ of Miami / Jackson Memorial Hosp
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Univ of Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Emory Univ
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Univ of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The CORE Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Methodist Hosp of Indiana / Life Care Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wishard Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ of Maryland (Pediatric)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
20201
Country
United States
Facility Name
Univ of Maryland, Institute of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Boston Med Ctr (Harvard)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Boston Med Ctr (Pediatric)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess - West Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Brigham and Women's Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Montefiore Med Ctr Adolescent AIDS Program
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Community Health Network
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-001
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
State Univ of New York at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948111
Country
United States
Facility Name
Univ of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Med Ctr
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
441091998
Country
United States
Facility Name
Univ of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Brown Univ / Miriam Hosp
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Brown Univ / The Miriam Hosp
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Miriam Hosp / Brown Univ
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Julio Arroyo
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
University of Washington (Seattle)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Univ of Puerto Rico / Univ Children's Hosp AIDS
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico
Facility Name
San Juan City Hosp
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs