Vaccine Therapy in Preventing HPV in HIV-Positive Women in India - Full Text View

Sponsors and Collaborators:	AIDS Associated Malignancies Clinical Trials Consortium National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00667563

Purpose

RATIONALE: Vaccines made from virus proteins may help the body build an effective immune response to prevent cervical cancer.

PURPOSE: This pilot study is looking at the side effects of a human papillomavirus vaccine and how well it works in preventing cervical cancer in women in India with HIV-1 infection.

Condition	Intervention
Cervical Cancer Precancerous/Nonmalignant Condition	Drug: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine Procedure: DNA analysis Procedure: colposcopic biopsy Procedure: cytology specimen collection procedure Procedure: polymerase chain reaction

MedlinePlus related topics: AIDS Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label
Official Title:	A Single-Arm, Open-Label Pilot Study of the Safety and Immunogenicity of the Merck Quadrivalent Human Papillomavirus Vaccine Among HIV-Positive Women in India

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety, in terms of grade 3 or 4 adverse events attributed to the vaccine, according to NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Significant decrease (at the 0.05 significance level) in CD4+ cell count or HIV RNA rise from baseline of ≥ 1.0 log10 in the level of quantification (or > 200 copies/mL in patients < 50 years old at study entry) [ Designated as safety issue: No ]
Detectable HPV antibody to HPV 16, 18, 6 or 11 at 1 month after the completion of HPV vaccination series (week 28) [ Designated as safety issue: No ]

Secondary Outcome Measures:

HPV antibody titers to types 6, 11, 16, and 18 at baseline and at weeks 8, 24, and 52 [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	April 2008
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Assess the safety of the Gardasil® quadrivalent human papillomavirus (HPV) (types 6, 11, 16,18) virus-like-particle vaccine with vs without prior exposure to one or more of the HPV types in the vaccine in HIV-positive women in Chennai, India.
Determine the effect of the vaccine on HIV viral load and CD4+/CD8+ levels in these patients.
Determine the proportion of these patients who respond serologically to the HPV vaccine and the kinetics of their response.

Secondary

Determine the prevalence and incidence of cervical intraepithelial neoplasia in these patients.
Determine the spectrum of cervical and oral HPV types in these patients at baseline, 9 months, and 1 year after vaccination.

OUTLINE: This is a multicenter study.

Patients receive quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and once in weeks 8 and 24.

Patients undergo cervical cell, buccal cell, and blood sample collection at baseline and periodically after vaccination for immunologic and virologic studies. Cervical cytology specimens are examined by polymerase chain reaction to detect HPV 6, 11, 16, or 18 DNA, as well as 35 other HPV types. Blood samples are analyzed for CD4+/CD8+ cell count, plasma HIV-1 RNA levels, and serum HPV antibody titers for HPV types 6, 11, 16, and 18. Some plasma samples will be stored for future HPV pseudovirion neutralization assays.

After completion of study therapy, patients are followed periodically for up to 12 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot prior to study entry
- HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
Meets 1 of the following criteria:
- Nadir CD4 level of < 250 cells/mm³ and receiving highly active antiretroviral therapy (HAART) for at least 6 months prior to study entry
- Nadir CD4 level of > 250 cells/mm³ and not receiving HAART at the time of study entry
No cervical intraepithelial neoplasia (CIN) or CIN 1 on cervical cytology or biopsy
No known history of high-grade CIN or cervical cancer

PATIENT CHARACTERISTICS:

Karnofsky performance status 70-100%
ANC > 750 cells/mm³
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000/mm³
Serum creatinine ≤ 3 times upper limit of normal (ULN)
AST and ALT ≤ 2.5 times ULN
Conjugated (direct) bilirubin ≤ 2.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active drug or alcohol use or dependence that would interfere with adherence to study requirements, in the opinion of the site Investigator
No serious illness requiring systemic treatment and/or hospitalization within the past 45 days
No allergy to yeast or any of the components of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 45 days since prior systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or intravenous immunoglobulin
- Routine standard of care, including hepatitis B, influenza, and tetanus vaccines are allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667563

Sponsors and Collaborators

AIDS Associated Malignancies Clinical Trials Consortium

National Cancer Institute (NCI)

Investigators

Study Chair:	Joel Palefsky, MD	UCSF Helen Diller Family Comprehensive Cancer Center
Investigator:	N. Kumarasamy, MD	YRG Care

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000593634, AMC-054
Study First Received:	April 25, 2008
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00667563
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

human papilloma virus infection
cervical cancer
cervical intraepithelial neoplasia
HIV infection

Study placed in the following topic categories:

Virus Diseases
Precancerous Conditions
HIV Seropositivity
HIV Infections
Cervical intraepithelial neoplasia

Acquired Immunodeficiency Syndrome
Papillomavirus Infections
Papilloma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009