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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.
Sponsor:
Collaborator:
Merck
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
History of Changes
  Purpose

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
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:

MedlinePlus related topics: Cancer HIV/AIDS
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
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

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. .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV seropositive women from South Africa, Botswana, and Brasil

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840905

Locations
Botswana
Shahin Lockman
Habarone, Botswana
Brazil
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
Investigators
Principal Investigator: Cynthia S Firnhaber, MD Clinical HIV Research Unit University of Witwatersrand
  More Information

No publications provided

Responsible Party: Cynthia S Firnhaber, Associate Professor of Medicine, University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier: NCT00840905     History of Changes
Other Study ID Numbers: Merck P0806
Study First Received: February 10, 2009
Last Updated: November 6, 2012
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by University of Witwatersrand, South Africa:
HPV

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

ClinicalTrials.gov processed this record on March 10, 2013