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
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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
  Description
Number of Participants Participants with Genital Warts

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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
New Cases Newly diagnosed cases of genital warts
Recurrent Cases Reappearance of genital warts at 3 or 6 months post-treatment in participants free of warts at completion of treatment
Persistent Cases The warts presence after completion of treatment
Total Total of all reporting groups

Baseline Measures
    New Cases     Recurrent Cases     Persistent Cases     Total  
Number of Participants  
[units: participants]
  94     40     22     156  
Age, Customized  
[units: Years]
Mean ( Full Range )
  28.64  
  ( 15 to 53 )  
  30.18  
  ( 18 to 49 )  
  29.91  
  ( 17 to 50 )  
  29.21  
  ( 15 to 53 )  
Gender  
[units: Partcipants]
       
Female     94     40     22     156  
Male     0     0     0     0  
Marital Status  
[units: Participants]
       
Single, Not Sexually Active     19     6     5     30  
Single, Sexually Active     56     27     9     92  
Married     13     4     4     21  
Separated / Divorced / Widow     6     3     4     13  
Age at First Sexual Intercourse  
[units: Participants]
       
14 or Less (Years)     9     2     1     12  
15 - 19 (Years)     69     33     14     116  
20 and Above (Years)     16     5     6     27  
Virgo Intacta (Years)     0     0     1     1  
Education Level  
[units: Participants]
       
Primary     13     0     3     16  
Secondary     67     36     13     116  
Tertiary     14     4     6     24  
Smoking  
[units: Participants]
       
Yes     9     3     4     16  
No     77     34     15     126  
Previously     8     3     3     14  
HIV Status  
[units: Participants]
       
Positive     71     36     16     123  
Negative     21     3     5     29  
Unknown     2     1     1     4  
Treatment Modalities  
[units: Participants]
       
Local Ablation with Tricholoroacetic Acid (TCA)     7     2     2     11  
Electrocautery under LA     68     28     13     109  
Electrocautery / Laser Ablation under GA     17     9     7     33  
TCA + Electrocautery     2     1     0     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HPV DNA and HIV Status   [ Time Frame: 18 Months ]
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Measure Type Primary
Measure Title HPV DNA and HIV Status
Measure Description HPV DNA Positivity and HIV Status
Time Frame 18 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only 126 out of 156 samples collected from each patients were analysed as 30 of the samples were contaminated, of which 22 were from HIV Positive patients and 8 were from HIV Negative patients.

Reporting Groups
  Description
HIV Positive Number of participants with HIV Positive
HIV Negative Number of participants with HIV Negative
HIV Unknown Number of participants who refused HIV Testing

Measured Values
    HIV Positive     HIV Negative     HIV Unknown  
Number of Participants Analyzed  
[units: participants]
  101     21     4  
HPV DNA and HIV Status  
[units: participants]
     
HPV Positive     96     19     4  
HPV Negative     5     2     0  

No statistical analysis provided for HPV DNA and HIV Status



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
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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