Trial Outcomes & Findings for Treatment of Oral Warts in HIV+ Patients (NCT NCT00454181)

NCT ID: NCT00454181

Last Updated: 2011-09-16

Results Overview

Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 59 participants
• Primary outcome timeframe: 24 weeks, from baseline to the end of treatment
• Results posted on: 2011-09-16

Participant Flow

Enrollment took place between January 2007 and March 2009 at 10 university-affiliated dental clinics across the US.

All 59 enrolled subjects were randomized to treatment and took at least 1 dose of assigned study drug.

Participant milestones

Measure	IFN Lozenges 500 IU Interferon-alpha lozenges for oral dissolution	Placebo Lozenges 200 mg lozenges containing anhydrous crystalline maltose
Overall Study STARTED	45	14
Overall Study COMPLETED	30	11
Overall Study NOT COMPLETED	15	3

Reasons for withdrawal

Measure	IFN Lozenges 500 IU Interferon-alpha lozenges for oral dissolution	Placebo Lozenges 200 mg lozenges containing anhydrous crystalline maltose
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	11	1
Overall Study Protocol Violation	1	1
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Treatment of Oral Warts in HIV+ Patients

Baseline characteristics by cohort

Measure	IFN Lozenges n=45 Participants 500 IU Interferon-alpha lozenges for oral dissolution	Placebo Lozenges n=14 Participants 200 mg lozenges containing anhydrous crystalline maltose	Total n=59 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	45 Participants n=5 Participants	14 Participants n=7 Participants	59 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	45.0 years STANDARD_DEVIATION 5.05 • n=5 Participants	46.6 years STANDARD_DEVIATION 5.43 • n=7 Participants	45.4 years STANDARD_DEVIATION 5.14 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	13 Participants n=7 Participants	53 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	14 participants n=7 Participants	59 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks, from baseline to the end of treatment

Population: Per protocol

Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area

Outcome measures

Measure	IFN Lozenges n=36 Participants 500 IU Interferon-alpha lozenges for oral dissolution	Placebo Lozenges n=12 Participants 200 mg lozenges containing anhydrous crystalline maltose
Change in Total Oral Mucosal Area Covered by Warts.	11 participants	2 participants

SECONDARY outcome

Timeframe: 24 weeks, from baseline to the end of treatment

Population: Per protocol - only a sub-set of subjects had lip warts at study entry

Number of subjects with a 75% or greater decrease from baseline to week 24 in total lip wart area

Outcome measures

Measure	IFN Lozenges n=13 Participants 500 IU Interferon-alpha lozenges for oral dissolution	Placebo Lozenges n=4 Participants 200 mg lozenges containing anhydrous crystalline maltose
Total Surface Area of the Lips Covered by Warts	5 participants	0 participants

SECONDARY outcome

Timeframe: 24 weeks, from baseline to the end of treatment

Number of subjects reporting change in oral warts from baseline to week 24 as "better." Scale was subjective with 3 choices: "better," "worse," or "unchanged."

Outcome measures

Measure	IFN Lozenges n=36 Participants 500 IU Interferon-alpha lozenges for oral dissolution	Placebo Lozenges n=12 Participants 200 mg lozenges containing anhydrous crystalline maltose
Subject Questionnaire Regarding Changes in Warts	18 participants	4 participants

SECONDARY outcome

Timeframe: 24 weeks, from baseline to end of treatment

Number of subjects reporting change in global oral health from baseline to week 24 as "better." Scale was subjective with 3 choices: "better," "worse," or "unchanged."

Outcome measures

Measure	IFN Lozenges n=36 Participants 500 IU Interferon-alpha lozenges for oral dissolution	Placebo Lozenges n=12 Participants 200 mg lozenges containing anhydrous crystalline maltose
Subject Questionnaire Regarding Global Oral Changes	14 participants	2 participants

SECONDARY outcome

Timeframe: 24 weeks, from baseline to the end of treatment

Number of subjects with improvement in oral warts from baseline to week 24 as rated by the attending investigator. Scale was subjective with 3 choices: "improved," "worsened," or "unchanged."

Outcome measures

Measure	IFN Lozenges n=36 Participants 500 IU Interferon-alpha lozenges for oral dissolution	Placebo Lozenges n=12 Participants 200 mg lozenges containing anhydrous crystalline maltose
Investigator Assessment Regarding Changes in Warts	13 participants	5 participants

SECONDARY outcome

Timeframe: 24 weeks, from baseline to the end of treatment

Number of subjects with improvement from baseline to week 24 in global oral health as rated by the attending investigator. Scale was subjective with 3 choices: "improved," "worsened," or "unchanged."

Outcome measures

Measure	IFN Lozenges n=36 Participants 500 IU Interferon-alpha lozenges for oral dissolution	Placebo Lozenges n=12 Participants 200 mg lozenges containing anhydrous crystalline maltose
Investigator Assessment Regarding Global Oral Changes.	9 participants	2 participants

Adverse Events

IFN Lozenges

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo Lozenges

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	IFN Lozenges n=45 participants at risk 500 IU Interferon-alpha lozenges for oral dissolution	Placebo Lozenges n=14 participants at risk 200 mg lozenges containing anhydrous crystalline maltose
Respiratory, thoracic and mediastinal disorders pneumonia	4.4% 2/45 • Number of events 2 • 6 months	0.00% 0/14 • 6 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) anal cancer	0.00% 0/45 • 6 months	7.1% 1/14 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders asthma	2.2% 1/45 • Number of events 1 • 6 months	0.00% 0/14 • 6 months
Gastrointestinal disorders esophageal ulcer	2.2% 1/45 • Number of events 1 • 6 months	0.00% 0/14 • 6 months

Other adverse events

Measure	IFN Lozenges n=45 participants at risk 500 IU Interferon-alpha lozenges for oral dissolution	Placebo Lozenges n=14 participants at risk 200 mg lozenges containing anhydrous crystalline maltose
Gastrointestinal disorders diarrhea	6.7% 3/45 • Number of events 3 • 6 months	0.00% 0/14 • 6 months
Surgical and medical procedures tooth extraction	6.7% 3/45 • Number of events 3 • 6 months	0.00% 0/14 • 6 months
Infections and infestations candidiasis	6.7% 3/45 • Number of events 5 • 6 months	7.1% 1/14 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders upper respiratory tract infection	2.2% 1/45 • Number of events 1 • 6 months	14.3% 2/14 • Number of events 2 • 6 months

Additional Information

Martin J. Cummins

Amarillo Biosciences, Inc.

Phone: 806-376-1741

Email: mcummins@amarbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60