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

Completed

Conditions studied: HIV Infections, Papilloma

In brief

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).

Key facts

Study ID

NCT00006444

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

160

Starts

2000-11-01

Expected to finish

2005-08-01

Last updated by the study team

2013-11-20

Who can join

Age: 13 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 D.C., 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 Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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