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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00006444

Collaborator

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

160

Enrollment

Locations

Duration (Months)

3.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Papilloma

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 Design

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

Study Start Date :

Nov 1, 2000

Actual Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Children's Hosp of Los Angeles/UCLA Med Ctr	Los Angeles	California	United States	900276016
3	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California	United States	900331079
4	Los Angeles County - USC Med Ctr	Los Angeles	California	United States	90033
5	UCLA CARE Ctr	Los Angeles	California	United States	90095
6	Univ of California, San Diego	San Diego	California	United States	92103
7	University of California San Francisco	San Francisco	California	United States	941104206
8	San Mateo County AIDS Program	Stanford	California	United States	94305-5107
9	Stanford Univ	Stanford	California	United States	94305-5107
10	Willow Clinic	Stanford	California	United States	94305-5107
11	Univ of Colorado Health Sciences Ctr, Denver	Denver	Colorado	United States	80262-3706
12	Howard Univ Hosp	Washington	District of Columbia	United States	20060
13	North Broward Hosp District	Fort Lauderdale	Florida	United States	33311
14	Univ of Florida Health Science Ctr / Pediatrics	Jacksonville	Florida	United States	32209
15	Univ of Miami School of Medicine	Miami	Florida	United States	331361013
16	Univ of Miami / Jackson Memorial Hosp	Miami	Florida	United States	33136
17	Univ of Miami (Pediatric)	Miami	Florida	United States	33161
18	Emory Univ	Atlanta	Georgia	United States	30308
19	Univ of Hawaii	Honolulu	Hawaii	United States	96816
20	Mt Sinai Hosp Med Ctr / Dept of Pediatrics	Chicago	Illinois	United States	60608
21	Northwestern Univ Med School	Chicago	Illinois	United States	60611
22	The CORE Ctr	Chicago	Illinois	United States	60612
23	Indiana Univ Hosp	Indianapolis	Indiana	United States	462025250
24	Methodist Hosp of Indiana / Life Care Clinic	Indianapolis	Indiana	United States	46202
25	Wishard Hosp	Indianapolis	Indiana	United States	46202
26	Univ of Maryland (Pediatric)	Baltimore	Maryland	United States	20201
27	Univ of Maryland, Institute of Human Virology	Baltimore	Maryland	United States	21201
28	Johns Hopkins Hosp	Baltimore	Maryland	United States	21287
29	Boston Med Ctr (Harvard)	Boston	Massachusetts	United States	02118
30	Boston Med Ctr (Pediatric)	Boston	Massachusetts	United States	02118
31	Beth Israel Deaconess - West Campus	Boston	Massachusetts	United States	02215
32	Brigham and Women's Hosp	Boston	Massachusetts	United States	02215
33	Montefiore Med Ctr Adolescent AIDS Program	Bronx	New York	United States	10467
34	Beth Israel Med Ctr	New York	New York	United States	10003
35	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
36	Columbia Presbyterian Med Ctr	New York	New York	United States	10032
37	Community Health Network	Rochester	New York	United States	14642-001
38	Univ of Rochester Medical Center	Rochester	New York	United States	14642
39	State Univ of New York at Stony Brook	Stony Brook	New York	United States	117948111
40	Univ of North Carolina	Chapel Hill	North Carolina	United States	275997215
41	Duke Univ Med Ctr	Durham	North Carolina	United States	27710
42	Case Western Reserve Univ	Cleveland	Ohio	United States	44106
43	MetroHealth Med Ctr	Cleveland	Ohio	United States	441091998
44	Univ of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
45	Brown Univ / Miriam Hosp	Providence	Rhode Island	United States	02906
46	Brown Univ / The Miriam Hosp	Providence	Rhode Island	United States	02906
47	Miriam Hosp / Brown Univ	Providence	Rhode Island	United States	02906
48	Julio Arroyo	West Columbia	South Carolina	United States	29169
49	University of Washington (Seattle)	Seattle	Washington	United States	98104
50	Univ of Puerto Rico / Univ Children's Hosp AIDS	San Juan		Puerto Rico	009365067
51	San Juan City Hosp	San Juan		Puerto Rico	009367344