Trial Outcomes & Findings for Typing of Human Papilloma Virus (HPV) From Female Genital Warts (NCT NCT01192282)
NCT ID: NCT01192282
Last Updated: 2013-01-24
Results Overview
HPV DNA Positivity and HIV Status
Recruitment status
COMPLETED
Target enrollment
156 participants
Primary outcome timeframe
18 Months
Results posted on
2013-01-24
Participant Flow
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.
No Applicable.
Participant milestones
| Measure |
Number of Participants
Participants with Genital Warts
|
|---|---|
|
Overall Study
STARTED
|
156
|
|
Overall Study
COMPLETED
|
156
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Typing of Human Papilloma Virus (HPV) From Female Genital Warts
Baseline characteristics by cohort
| Measure |
New Cases
n=94 Participants
Newly diagnosed cases of genital warts
|
Recurrent Cases
n=40 Participants
Reappearance of genital warts at 3 or 6 months post-treatment in participants free of warts at completion of treatment
|
Persistent Cases
n=22 Participants
The warts presence after completion of treatment
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
28.64 Years
n=5 Participants
|
30.18 Years
n=7 Participants
|
29.91 Years
n=5 Participants
|
29.21 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Marital Status
Single, Not Sexually Active
|
19 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Marital Status
Single, Sexually Active
|
56 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Marital Status
Married
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Marital Status
Separated / Divorced / Widow
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age at First Sexual Intercourse
14 or Less (Years)
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age at First Sexual Intercourse
15 - 19 (Years)
|
69 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Age at First Sexual Intercourse
20 and Above (Years)
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Age at First Sexual Intercourse
Virgo Intacta (Years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Education Level
Primary
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Education Level
Secondary
|
67 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Education Level
Tertiary
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Smoking
Yes
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Smoking
No
|
77 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Smoking
Previously
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
HIV Status
Positive
|
71 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
|
HIV Status
Negative
|
21 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
HIV Status
Unknown
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Treatment Modalities
Local Ablation with Tricholoroacetic Acid (TCA)
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Treatment Modalities
Electrocautery under LA
|
68 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Treatment Modalities
Electrocautery / Laser Ablation under GA
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Treatment Modalities
TCA + Electrocautery
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 18 MonthsPopulation: 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.
HPV DNA Positivity and HIV Status
Outcome measures
| Measure |
HIV Positive
n=101 Participants
Number of participants with HIV Positive
|
HIV Negative
n=21 Participants
Number of participants with HIV Negative
|
HIV Unknown
n=4 Participants
Number of participants who refused HIV Testing
|
|---|---|---|---|
|
HPV DNA and HIV Status
HPV Positive
|
96 participants
|
19 participants
|
4 participants
|
|
HPV DNA and HIV Status
HPV Negative
|
5 participants
|
2 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 18 MonthsPopulation: Only 118 out of 119 patients with HPV DNA Positive had a Pap Smear done. One patient was a Virgin and hence no Pap Smear was done.
Relationship between HPV DNA Positivity and Pap Smear Results
Outcome measures
| Measure |
HIV Positive
n=118 Participants
Number of participants with HIV Positive
|
HIV Negative
n=7 Participants
Number of participants with HIV Negative
|
HIV Unknown
Number of participants who refused HIV Testing
|
|---|---|---|---|
|
HPV DNA and Pap Smear Results
Normal
|
42 Participants
|
5 Participants
|
—
|
|
HPV DNA and Pap Smear Results
Low Grade Squamous Intraepithelial Lesion
|
59 Participants
|
2 Participants
|
—
|
|
HPV DNA and Pap Smear Results
High Grade Squamous Intraepithelial Lesion
|
10 Participants
|
0 Participants
|
—
|
|
HPV DNA and Pap Smear Results
Atypical Squamous Cell of Undetermined Significanc
|
6 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: 119 out of 126 uncontaminated samples were HPV DNA Positive. Out of these 119 HPV DNA Positive Samples, 12 were B-Globin Positive but no specific HPV Genotype could be identifiable.
Number of HPV Genotypes isolated according to HIV Status
Outcome measures
| Measure |
HIV Positive
n=96 Participants
Number of participants with HIV Positive
|
HIV Negative
n=19 Participants
Number of participants with HIV Negative
|
HIV Unknown
n=4 Participants
Number of participants who refused HIV Testing
|
|---|---|---|---|
|
Number of HPV Genotypes Isolated by HIV Status
8 HPV Genotype
|
1 participants
|
0 participants
|
0 participants
|
|
Number of HPV Genotypes Isolated by HIV Status
9 HPV Genotype
|
1 participants
|
0 participants
|
0 participants
|
|
Number of HPV Genotypes Isolated by HIV Status
1 HPV Genotype
|
44 participants
|
14 participants
|
1 participants
|
|
Number of HPV Genotypes Isolated by HIV Status
2 HPV Genotype
|
12 participants
|
1 participants
|
2 participants
|
|
Number of HPV Genotypes Isolated by HIV Status
3 HPV Genotype
|
9 participants
|
2 participants
|
0 participants
|
|
Number of HPV Genotypes Isolated by HIV Status
4 HPV Genotype
|
4 participants
|
0 participants
|
0 participants
|
|
Number of HPV Genotypes Isolated by HIV Status
5 HPV Genotype
|
5 participants
|
0 participants
|
0 participants
|
|
Number of HPV Genotypes Isolated by HIV Status
6 HPV Genotype
|
3 participants
|
0 participants
|
0 participants
|
|
Number of HPV Genotypes Isolated by HIV Status
7 HPV Genotype
|
5 participants
|
0 participants
|
0 participants
|
|
Number of HPV Genotypes Isolated by HIV Status
11 HPV Genotype
|
2 participants
|
0 participants
|
0 participants
|
|
Number of HPV Genotypes Isolated by HIV Status
15 HPV Genotype
|
1 participants
|
0 participants
|
0 participants
|
|
Number of HPV Genotypes Isolated by HIV Status
No Genotype Isolated but B-Globin Positive
|
9 participants
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 18 months10 commonest types of HPV isolated according to HIV status
Outcome measures
| Measure |
HIV Positive
n=101 Participants
Number of participants with HIV Positive
|
HIV Negative
n=21 Participants
Number of participants with HIV Negative
|
HIV Unknown
Number of participants who refused HIV Testing
|
|---|---|---|---|
|
Commonest HPV Genotypes Isolated by HIV Status
HPV 11
|
46 Participants
|
10 Participants
|
—
|
|
Commonest HPV Genotypes Isolated by HIV Status
HPV 6
|
33 Participants
|
9 Participants
|
—
|
|
Commonest HPV Genotypes Isolated by HIV Status
HPV 89
|
19 Participants
|
0 Participants
|
—
|
|
Commonest HPV Genotypes Isolated by HIV Status
HPV 61
|
16 Participants
|
0 Participants
|
—
|
|
Commonest HPV Genotypes Isolated by HIV Status
HPV 55
|
12 Participants
|
0 Participants
|
—
|
|
Commonest HPV Genotypes Isolated by HIV Status
HPV 62
|
12 Participants
|
0 Participants
|
—
|
|
Commonest HPV Genotypes Isolated by HIV Status
HPV 81
|
9 Participants
|
0 Participants
|
—
|
|
Commonest HPV Genotypes Isolated by HIV Status
HPV 16
|
8 Participants
|
0 Participants
|
—
|
|
Commonest HPV Genotypes Isolated by HIV Status
HPV 18
|
8 Participants
|
0 Participants
|
—
|
|
Commonest HPV Genotypes Isolated by HIV Status
HPV 45
|
8 Participants
|
0 Participants
|
—
|
Adverse Events
HIV Positive
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
HIV Negative
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
HIV Unknown
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HIV Positive
n=123 participants at risk
Participants with Genital Warts who were HIV Positive
|
HIV Negative
n=29 participants at risk
Participants with Genital Warts who were HIV Negative
|
HIV Unknown
n=4 participants at risk
Participants with Genital Warts whom HIV Status was Unknown
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Warts Recurrence
|
22.8%
28/123 • Number of events 28 • 1 year and 10 months
Adverse event here referred to developement of warts recurrent after treatment.
|
17.2%
5/29 • Number of events 5 • 1 year and 10 months
Adverse event here referred to developement of warts recurrent after treatment.
|
0.00%
0/4 • 1 year and 10 months
Adverse event here referred to developement of warts recurrent after treatment.
|
Additional Information
Dr Shahila Tayib
Groote Schurr Hospital / University of Cape Town
Phone: 0060195773376
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place