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

HIV Infections Clinical Trial

Official title:

A Pilot Observational Study to Determine the Prevalence of HPV Serology in HIV Seropositive Women From Subsaharan Africa and Brasil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840905
• Other study ID #: Merck P0806
• Status: Completed
• Phase: N/A
• First received: February 10, 2009
• Last updated: November 6, 2012
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2012
• Source: University of Witwatersrand, South Africa
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV
• HIV Infections

Locations

Country	Name	City	State
Botswana	Shahin Lockman	Habarone
Brazil	Fundacao Oswaldo Cruz	Rio De Janeiro
South Africa	University of Witwatersrand/Helen Joseph Hospital	Johannesburg

Sponsors (2)

Lead Sponsor	Collaborator
Cynthia S Firnhaber	Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

Botswana,  Brazil,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the seroprevalence of HPV types 6,11,16,18 in HIV serOpositive women for Botswana, South Africa and Brazil		2 years	No