Status:
COMPLETED
Vaccine Therapy in Preventing HPV in HIV-Positive Women in India
Lead Sponsor:
AIDS Malignancy Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
The Emmes Company, LLC
Conditions:
Cervical Cancer
Nonneoplastic Condition
Eligibility:
FEMALE
18-120 years
Phase:
PHASE1
Brief Summary
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 papil...
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...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot before 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 ≤ 350 cells/mm³ and receiving highly active antiretroviral therapy (HAART) for at least 6 months before study entry
- Nadir CD4 level of \> 350 cells/mm³ and not receiving HAART at the time of study entry
- 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 ≤ 3.0 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
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00667563
Start Date
August 1 2009
End Date
November 1 2012
Last Update
March 19 2024
Active Locations (1)
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1
YRG Care
Chennai, India, 600113