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A Study to Examine the Human Papillomavirus Types Exposure in Women From Southern Africa and Brasil

NCT ID: NCT00840905

Last Updated: 2012-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

487 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-12-31

Brief Summary

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This is a study to determine what Human Papillomavirus HIV seropositive women in Botswana, South Africa and Brasil have been exposed to during their life. The Human Papillomavirus causes cervical cancer. Different types are more likely to lead to cancer than other types. A vaccine has been made to fight infection against HPV 16 and 18 which has been shown to cause cervical cancer in America and Europe. What HPV type cause cancer in other countries is not as well studied.

Hypothesis HPV serology will demonstrate that exposure to each HPV type in Gardisil (6,11,16,18) will be \<50% in HIV seropositive women in resource limited countries.

Detailed Description

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Plasma from HIV seropositive women will be taken and sent to MERCK in the USA to evaluate what the antibody titers of HPV 6,11,16 and 18. .

Conditions

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HIV HIV Infections

Keywords

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HPV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

HIV seropositive women from an HIV Antiretroviral therapy clinic in Johannesburg South Africa

No interventions assigned to this group

2

A cohort of HIV seropositive women from Gabarone Botswana

No interventions assigned to this group

3

A cohort of HIV seropositive women from Rio De Janeiro Brasil

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* HIV seropositive women 18 years of age and older Consent signed per local IRB requirement

Exclusion Criteria

* Can not give blood
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Cynthia S Firnhaber

OTHER

Sponsor Role lead

Responsible Party

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Cynthia S Firnhaber

Associate Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Cynthia S Firnhaber, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical HIV Research Unit University of Witwatersrand

Locations

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Shahin Lockman

Habarone, , Botswana

Site Status

Fundacao Oswaldo Cruz

Rio de Janeiro, , Brazil

Site Status

University of Witwatersrand/Helen Joseph Hospital

Johannesburg, , South Africa

Site Status

Countries

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Botswana Brazil South Africa

Other Identifiers

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Merck P0806

Identifier Type: -

Identifier Source: org_study_id