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Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women | Clinical Trials | Clareo Health

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Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women

Immunogenicity, Safety, Tolerability, and Behavioral Consequences of an HPV-6, -11, -16, -18 Vaccine in HIV-Infected Young Women

NCT00710593•University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.

Eligibility

Age

16 - 23 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Young women age 16 years and 0 days to 23 years and 364 days
•HIV-infection after the age of 9 years as documented by a positive result on any of the following licensed tests: any antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA polymerase chain reaction (PCR), or plasma HIV-1 RNA \> 1,000 copies/ml
•HIV treatment history that falls in one of the following categories:
•Group A: ART naïve or if ART-exposed, has not received HAART for at least the six months prior to study entry Group B: Has been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads \< 400 copies/ml on two previous clinical visits within the 6 months prior to study entry
•Willingness to avoid pregnancy from study entry through the Week 28 visit for subjects of child-bearing potential, i.e., use of at least one barrier or hormonal method; e.g., condoms, Depo-Provera, oral contraceptive pills, etc. Subjects on antiretroviral (ARV) medications must use a barrier contraceptive method because ARV medications can make hormonal birth control less effective.
•Anticipated ability and willingness to complete all study vaccines and evaluations
•Ability and willingness to participate in the study by providing written informed consent

Exclusion Criteria

•History of any prior vaccination with an HPV vaccine
•Active anogenital warts within three months prior to study entry) or history of cervical intraepithelial neoplasia (CIN) 2/3 (ever, must be documented by colposcopy)
•Previous allergic reaction to any constituents of the HPV vaccine
•Pregnancy
•Active substance use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study
•Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the time of study entry
•Presence of any known \> Grade 3 clinical or laboratory toxicity at the time of study entry (per the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Toxicity Tables, see ATN MOGO) with the exception of isolated Grade 3 serum total hyperbilirubinemia that is considered due to atazanavir (see Section 9.6 for definition of isolated total hyperbilirubinemia).
•Receipt of any routine vaccine within four weeks prior to study entry
•Receipt of any immune globulin or plasma product within six months prior study entry
•Receipt of any blood product or transfusion, other than immune globulin or plasma as noted above, within four weeks prior to study entry
+6 more criteria

Locations (14)

Childrens Hospital of Los Angeles

Los Angeles, California, United States

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Childrens Diagnostic & Treatment Center

Fort Lauderdale, Florida, United States

University of Miami School of Medicine

Miami, Florida, United States

USF College of Medicine

Tampa, Florida, United States

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

Chicago, Illinois, United States

Childrens Memorial Hospital

Chicago, Illinois, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

University of Maryland

Baltimore, Maryland, United States

Mount Sinai Medical Center

New York, New York, United States

Key Dates

Start Date

February 1, 2008

Primary Completion Date

February 1, 2011

Completion Date

February 1, 2011

Last Updated

July 2, 2017

Enrollment

ACTUAL participants

Conditions

HIV Infection

Interventions

HPV vaccine for strains -6, -11, -16, and -18

BIOLOGICAL

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RECRUITING

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HIVHIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women

Inclusion Criteria

Exclusion Criteria

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