Trial Outcomes & Findings for The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata (NCT NCT00941889)

Last Updated: 2016-07-25

Results Overview

Persistence of anal warts will be measured by the presence of any lesions at one month follow-up after surgery. Recurrence of anal warts will be measured by the development of new lesions after one month of follow-up.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment

Results posted on

2016-07-25

Participant Flow

Patients were recruited during office visits.

Participant milestones

Participant milestones
Measure	Placebo Patients who are in the control group will receive a placebo of saline at initial date, 2 months and 6 months.	Gardasil Group The treatment group will receive a 0.5 mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.
Overall Study STARTED	17	15
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	12	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=17 Participants Patients in this group received placebo of saline at initial date, 2 months and 6 months after enrollment.	Gardasil n=15 Participants Patients in this group received Gardasil injection at initial date, 2 months and 6 months after enrollment.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36 years STANDARD_DEVIATION 10 • n=5 Participants	37 years STANDARD_DEVIATION 13 • n=7 Participants	37 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	15 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment

Population: Five patients from the placebo group and seven patients from the gardasil group completed all three injections per the protocol. The remaining patients did not complete study-required follow-up and therefore could not be analyzed. One patient from the Gardasil Group and one patient from the placebo group met the outcome measure of recurrence.

Outcome measures

Outcome measures
Measure	Placebo Group n=5 Participants Patients who received placebo of saline at initial visit, 2 months and 6 months after enrollment.	Gardasil Group n=7 Participants Patients who received Gardasil injection at initial visit, 2 months, and 6 months after enrollment.
The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.	1 participants	1 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven Hunt, MD

Washington University

Phone: 314-454-7177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place