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NCT00006444 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00006444
Other study ID # A5029
Secondary ID AACTG A5029ACTG
Status Completed
Phase N/A
First received November 3, 2000
Last updated November 19, 2013
Start date November 2000
Est. completion date August 2005

Study information
Verified date November 2013
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 13 Years and older
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico San Juan City Hosp San Juan
Puerto Rico Univ of Puerto Rico / Univ Children's Hosp AIDS San Juan
United States Emory Univ Atlanta Georgia
United States Johns Hopkins Hosp Baltimore Maryland
United States Univ of Maryland (Pediatric) Baltimore Maryland
United States Univ of Maryland, Institute of Human Virology Baltimore Maryland
United States Univ of Alabama at Birmingham Birmingham Alabama
United States Beth Israel Deaconess - West Campus Boston Massachusetts
United States Boston Med Ctr (Harvard) Boston Massachusetts
United States Boston Med Ctr (Pediatric) Boston Massachusetts
United States Brigham and Women's Hosp Boston Massachusetts
United States Montefiore Med Ctr Adolescent AIDS Program Bronx New York
United States Univ of North Carolina Chapel Hill North Carolina
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 Case Western Reserve Univ Cleveland Ohio
United States MetroHealth Med Ctr Cleveland Ohio
United States Univ of Colorado Health Sciences Ctr, Denver Denver Colorado
United States Duke Univ Med Ctr Durham North Carolina
United States North Broward Hosp District Fort Lauderdale Florida
United States Univ of Hawaii Honolulu Hawaii
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 Florida Health Science Ctr / Pediatrics Jacksonville Florida
United States Children's Hosp of Los Angeles/UCLA 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 Southern California / LA County USC Med Ctr Los Angeles California
United States Univ of Miami (Pediatric) Miami Florida
United States Univ of Miami / Jackson Memorial Hosp Miami Florida
United States Univ of Miami School of Medicine Miami Florida
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Beth Israel Med Ctr New York New York
United States Columbia Presbyterian Med Ctr New York New York
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 Community Health Network Rochester New York
United States Univ of Rochester Medical Center Rochester New York
United States Univ of California, San Diego San Diego California
United States University of California San Francisco San Francisco California
United States University of Washington (Seattle) Seattle Washington
United States San Mateo County AIDS Program Stanford California
United States Stanford Univ Stanford California
United States Willow Clinic Stanford California
United States State Univ of New York at Stony Brook Stony Brook New York
United States Howard Univ Hosp Washington District of Columbia
United States Julio Arroyo West Columbia South Carolina

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

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