Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Shahila Tayib, University of Cape Town
ClinicalTrials.gov Identifier:
NCT01192282
First received: August 31, 2010
Last updated: January 18, 2013
Last verified: January 2013
Results First Received: 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
  Hide Participant Flow

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
  Description
Number of Participants Participants with Genital Warts

Participant Flow:   Overall Study
    Number of Participants  
STARTED     156  
COMPLETED     156  
NOT COMPLETED     0  



  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
  Hide Limitations and Caveats

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
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Shahila Tayib
Organization: Groote Schurr Hospital / University of Cape Town
phone: 0060195773376
e-mail: syarq@yahoo.com


No publications provided


Responsible Party: Shahila Tayib, University of Cape Town
ClinicalTrials.gov Identifier: NCT01192282     History of Changes
Other Study ID Numbers: 131/2010
Study First Received: August 31, 2010
Results First Received: December 15, 2012
Last Updated: January 18, 2013
Health Authority: South Africa: Human Research Ethics Committee