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Typing of Human Papilloma Virus (HPV) From Female Genital Warts

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 1, 2010
Last Update Posted: January 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Shahila Tayib, University of Cape Town
Results First Submitted: December 15, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Genital Warts
Human Papilloma Virus
Intervention: Procedure: Medical / Surgical Treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All female patients with genital warts referred to the Colposcopy Clinic of Groote Schuur Hospital, Cape Town, South Africa between 1st April 2010 and 30 September 2010. Those who were pregnant or too frail or ill for a gynaecological examination were excluded.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No Applicable.

Reporting Groups
Number of Participants Participants with Genital Warts

Participant Flow:   Overall Study
    Number of Participants
STARTED   156 

  Baseline Characteristics

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HPV DNA and HIV Status   [ Time Frame: 18 Months ]

2.  Primary:   HPV DNA and Pap Smear Results   [ Time Frame: 18 Months ]

3.  Primary:   Number of HPV Genotypes Isolated by HIV Status   [ Time Frame: Up to 18 months ]

4.  Primary:   Commonest HPV Genotypes Isolated by HIV Status   [ Time Frame: 18 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Thirty (19.2%) specimens had to be rejected due to contamination that occurred during the analysis process. During the HPV DNA analysis, there were protocols for different aspect of controls during the analysis which needed to be negative.

  More Information