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

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Cynthia S Firnhaber, University of Witwatersrand, South Africa Identifier:
First received: February 10, 2009
Last updated: November 6, 2012
Last verified: November 2012

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.

HIV HIV Infections

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Cynthia S Firnhaber, University of Witwatersrand, South Africa:

Primary Outcome Measures:
  • 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

Enrollment: 487
Study Start Date: February 2009
Study Completion Date: December 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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

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. .

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: February 10, 2009
Last Updated: November 6, 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 processed this record on September 19, 2017