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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Cynthia S Firnhaber, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier:
NCT00840905
First received: February 10, 2009
Last updated: November 6, 2012
Last verified: November 2012

February 10, 2009
November 6, 2012
February 2009
March 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00840905 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Examine the Human Papillomavirus Types Exposure in Women From Southern Africa and Brasil
A Pilot Observational Study to Determine the Prevalence of HPV Serology in HIV Seropositive Women From Subsaharan Africa and Brasil

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.

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. .

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   None Retained
Description:

Blood /plasma specimen 10cc

Non-Probability Sample

HIV seropositive women from South Africa, Botswana, and Brasil

  • HIV
  • HIV Infections
Not Provided
  • 1
    HIV seropositive women from an HIV Antiretroviral therapy clinic in Johannesburg South Africa
  • 2
    A cohort of HIV seropositive women from Gabarone Botswana
  • 3
    A cohort of HIV seropositive women from Rio De Janeiro Brasil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
487
December 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Can not give blood
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Botswana,   Brazil,   South Africa
 
NCT00840905
Merck P0806
No
Cynthia S Firnhaber, University of Witwatersrand, South Africa
Cynthia S Firnhaber
Merck Sharp & Dohme Corp.
Principal Investigator: Cynthia S Firnhaber, MD Clinical HIV Research Unit University of Witwatersrand
University of Witwatersrand, South Africa
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP