Evaluation of Gardasil immunogenicity in HIV+ vs HIV- teenagers.

• Conditions: HIV+ teenagers and young adults versus HIV-negative subjects: high-risk population for HPV-related disease.; MedDRA version: 14.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-002193-23-IT
• Lead Sponsor: AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-05
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

For both HIV-infected and healthy subjects:
•Subjects aged 13-27 years
•Females or males
•Written informed consent from parent or guardian if applicable (age <18 years)

For HIV-infected subjects:
•HIV-positive
•Asymptomatic subjects (possible with only generalized lymphadenopathy).
•Lymphocyte CD4+ count > 350 cell/mm3
•For subjects receiving HAART:
-Goog compliance to therapy
-At least two suppressed viral loads HIV-RNA (<37cp/ml) during 6 months prior to enrollment in study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

For female subjects (both HIV-infected and healthy) :
•Current (within 6 months prior to study entry) abnormal Pap test with confirmed biopsy results of cervical intraepithelial neoplasia CIN 2/3 caused by genotype HPV 16, 18 or cervical cancer within 180 days prior to study entry.
•Pregnancy or breastfeeding
•Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded

For both females and males (HIV-infected and healthy):
•Prior vaccination with quadrivalent HPV vaccine (Gardasil) before study entry.
•History of severe allergic reaction after previous vaccination or hypersensytivity to any vaccine component
•Any serious chronic or progressive disease (other than HIV) according to the judgment of the investigator:
-Acute infection requiring therapy or fever at time of enrollment
-Chronic autoimmune or oncologic disease receiving chemotherapy
-Tuberculosis
-Neurologic disease or history of convulsions
•Concomitant therapies (other than HAART):
-Chronic therapy ( for more than 14 days consecutively) with immunosoppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry.
-Ongoing anti-tubercular therapy
-Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry
•Severe anemia: hemoglobin less than 8.0 g/dL.
•Acute or chronic impairment of pulmonary, cardiac, hepatic o renal function.
•Use of investigational agents within 4 weeks prior to study enrollment.
•Current drug or alcohol use or dependence
•Documented history of non-adherence to antiretroviral treatment regimen within 12 months prior to study entry.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified