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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00840905
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : November 7, 2012
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Cynthia S Firnhaber, University of Witwatersrand, South Africa

Brief Summary:

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.

Condition or disease
HIV HIV Infections

Detailed Description:
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. .

Study Type : Observational
Actual Enrollment : 487 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Pilot Observational Study to Determine the Prevalence of HPV Serology in HIV Seropositive Women From Subsaharan Africa and Brasil
Study Start Date : February 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

HIV seropositive women from an HIV Antiretroviral therapy clinic in Johannesburg South Africa
A cohort of HIV seropositive women from Gabarone Botswana
A cohort of HIV seropositive women from Rio De Janeiro Brasil

Primary Outcome Measures :
  1. To determine the seroprevalence of HPV types 6,11,16,18 in HIV serOpositive women for Botswana, South Africa and Brazil [ Time Frame: 2 years ]

Biospecimen Retention:   None Retained
Blood /plasma specimen 10cc

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV seropositive women from South Africa, Botswana, and Brasil

Inclusion Criteria:

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

Exclusion Criteria:

  • Can not give blood

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00840905

Shahin Lockman
Habarone, Botswana
Fundacao Oswaldo Cruz
Rio De Janeiro, Brazil
South Africa
University of Witwatersrand/Helen Joseph Hospital
Johannesburg, South Africa
Sponsors and Collaborators
Cynthia S Firnhaber
Merck Sharp & Dohme Corp.
Principal Investigator: Cynthia S Firnhaber, MD Clinical HIV Research Unit University of Witwatersrand

Responsible Party: Cynthia S Firnhaber, Associate Professor of Medicine, University of Witwatersrand, South Africa Identifier: NCT00840905     History of Changes
Other Study ID Numbers: Merck P0806
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012

Keywords provided by Cynthia S Firnhaber, University of Witwatersrand, South Africa:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases