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

Completed

• Conditions: HIV; HIV Infections

• Registration Number: NCT00840905
• Lead Sponsor: Cynthia S Firnhaber

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.

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2010-03
• Study Completion: 2010-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-06
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 487

Inclusion Criteria

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

Exclusion Criteria

• Can not give blood

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the seroprevalence of HPV types 6,11,16,18 in HIV serOpositive women for Botswana, South Africa and Brazil	2 years

Trial Locations

Locations (3)

University of Witwatersrand/Helen Joseph Hospital; 🇿🇦 Johannesburg, South Africa

Shahin Lockman; 🇧🇼 Habarone, Botswana

Fundacao Oswaldo Cruz; 🇧🇷 Rio De Janeiro, Brazil