Trial Outcomes & Findings for Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus (NCT NCT00550589)
NCT ID: NCT00550589
Last Updated: 2015-12-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
6 weeks after treatment discontinuation
Results posted on
2015-12-21
Participant Flow
Participant milestones
| Measure |
Cidofovir
1.0% topical cidofovir cream
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus
Baseline characteristics by cohort
| Measure |
Cidofovir
n=33 Participants
1.0% topical cidofovir cream
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after treatment discontinuationOutcome measures
| Measure |
Cidofovir
n=33 Participants
1.0% topical cidofovir cream
|
|---|---|
|
Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL)
|
0.515 proportion of participants
|
PRIMARY outcome
Timeframe: Every 2 weeks on study, 6 weeks after treatment discontinuationPopulation: All enrolled patients
Number of study patients who had a serious adverse event
Outcome measures
| Measure |
Cidofovir
n=33 Participants
1.0% topical cidofovir cream
|
|---|---|
|
Safety and Tolerability of Topical Cidofovir as Assessed by NCI CTCAE v3.0
|
3 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Number of patients with tissue samples available at baseline
Number of patients with HPV16 at baseline in perianal HSIL and normal perianal tissue
Outcome measures
| Measure |
Cidofovir
n=30 Participants
1.0% topical cidofovir cream
|
|---|---|
|
Human Papilloma Virus (HPV) DNA Type in Perianal HSIL and Normal Perianal Tissue
|
16 participants
|
SECONDARY outcome
Timeframe: 6 weeks after treatment discontinuationPopulation: Participants who had a partial or complete response and for whom pre and post-treatment HPV data were available
Number of patients who cleared HPV among those who had a complete or partial response
Outcome measures
| Measure |
Cidofovir
n=12 Participants
1.0% topical cidofovir cream
|
|---|---|
|
Correlation of Clinical Regression of Perianal HSIL With Clearance of HPV DNA
|
2 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Number of patients with anal swabs or cytobrush results at baseline
Number of patients with HPV16 type present in the anus from anal swab or cytobrush at baseline
Outcome measures
| Measure |
Cidofovir
n=32 Participants
1.0% topical cidofovir cream
|
|---|---|
|
Identification of HPV-DNA Types Present in the Anus
|
14 participants
|
SECONDARY outcome
Timeframe: Baseline, after cycle 1, and 6 weeks after treatment discontinuationPopulation: The lab analysis of genes was not performed
Identification of abnormally methylated genes in perianal dysplasia
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, after cycle 1, and 6 weeks after treatment discontinuationPopulation: The gene analysis was not done
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, after cycle 1, and 6 weeks after treatment discontinuationPopulation: The gene expression analysis was not done
Outcome measures
Outcome data not reported
Adverse Events
Cidofovir
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cidofovir
n=33 participants at risk
1.0% topical cidofovir cream
|
|---|---|
|
Infections and infestations
Cellulitis
|
3.0%
1/33 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
3.0%
1/33 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin
|
6.1%
2/33 • Number of events 2
|
Other adverse events
| Measure |
Cidofovir
n=33 participants at risk
1.0% topical cidofovir cream
|
|---|---|
|
Metabolism and nutrition disorders
AST,SGOT Elevation
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
9.1%
3/33 • Number of events 3
|
|
Gastrointestinal disorders
Constitutional Symptoms
|
12.1%
4/33 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
4/33 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin
|
39.4%
13/33 • Number of events 21
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
6/33 • Number of events 8
|
|
General disorders
Fatigue
|
9.1%
3/33 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin
|
9.1%
3/33 • Number of events 3
|
|
Renal and urinary disorders
Hemoglobinuria
|
6.1%
2/33 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemorrhage, Anus
|
15.2%
5/33 • Number of events 7
|
|
Gastrointestinal disorders
Hemorrhage, Rectum
|
6.1%
2/33 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemorrhage, other
|
12.1%
4/33 • Number of events 5
|
|
Infections and infestations
Infection, other
|
9.1%
3/33 • Number of events 3
|
|
Infections and infestations
Infection, lung
|
6.1%
2/33 • Number of events 2
|
|
Infections and infestations
Infection, upper airway
|
6.1%
2/33 • Number of events 2
|
|
Infections and infestations
Infection, vagina
|
6.1%
2/33 • Number of events 2
|
|
Metabolism and nutrition disorders
Metabolic, other
|
18.2%
6/33 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
12.1%
4/33 • Number of events 11
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.1%
3/33 • Number of events 6
|
|
General disorders
Pain, other
|
6.1%
2/33 • Number of events 3
|
|
Gastrointestinal disorders
Pain, anus
|
27.3%
9/33 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Pain, back
|
6.1%
2/33 • Number of events 2
|
|
General disorders
Headache
|
18.2%
6/33 • Number of events 7
|
|
General disorders
Pain, perineum
|
42.4%
14/33 • Number of events 49
|
|
Renal and urinary disorders
Proteinuria
|
21.2%
7/33 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
11/33 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary, other
|
6.1%
2/33 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
6.1%
2/33 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
36.4%
12/33 • Number of events 25
|
|
Gastrointestinal disorders
Vomiting
|
15.2%
5/33 • Number of events 5
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
3/33 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, other
|
6.1%
2/33 • Number of events 2
|
|
Infections and infestations
Infection, skin
|
18.2%
6/33 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
51.5%
17/33 • Number of events 30
|
|
Infections and infestations
Upper respiratory infection
|
6.1%
2/33 • Number of events 2
|
|
Infections and infestations
Vaginal infection
|
9.1%
3/33 • Number of events 4
|
Additional Information
Jeannette Lee
Statistical Center of AIDS Malignancy Consortium
Phone: (501) 526-6712
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place