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Trial record 3 of 3132 for:    HIV Infections | NIH

Interferon Alpha 2b Intensification in HIV-Positive Individuals on Antiretroviral Therapy

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ClinicalTrials.gov Identifier: NCT01295515
Recruitment Status : Completed
First Posted : February 14, 2011
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Frank Maldarelli, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infection
Intervention Drug: Pegylated Interferon Alpha 2b (PEGINTRON)
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Interferon Treatment
Hide Arm/Group Description

Interferon treatment

Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b

Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Interferon Treatment
Hide Arm/Group Description

Interferon treatment

Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b

Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
HIV-infected individuals undergoing antiretroviral therapy
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  85.7%
>=65 years
1
  14.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
48.85  (9.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
0
   0.0%
Male
7
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Hispanic or Latino
1
  14.3%
Not Hispanic or Latino
6
  85.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  14.3%
White
5
  71.4%
More than one race
0
   0.0%
Unknown or Not Reported
1
  14.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
 100.0%
1.Primary Outcome
Title Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA)
Hide Description Cell associated HIV nucleic acid levels were measured using a single copy assay, and numbers of cells were quantified using a polymerase chain reaction method that detects RNA.
Time Frame week 4 (post) compared to week 0 (pre)
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 7 participants were analyzed overall and each row of data represents each participant's analyzed data.
Arm/Group Title Interferon Treatment
Hide Arm/Group Description:

Interferon treatment

Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: # of copies of HIV RNA/million cells
Patient #1 HIV RNA Pre Number Analyzed 1 participants
670
Patient #1 HIV RNA Post Number Analyzed 1 participants
180
Patient #2 HIV RNA Pre Number Analyzed 1 participants
90
Patient #2 HIV RNA Post Number Analyzed 1 participants
130
Patient #3 HIV RNA Pre Number Analyzed 1 participants
810
Patient #3 HIV RNA Post Number Analyzed 1 participants
420
Patient #4 HIV RNA Pre Number Analyzed 1 participants
450
Patient #4 HIV RNA Post Number Analyzed 1 participants
390
Patient #5 HIV RNA Pre Number Analyzed 1 participants
12
Patient #5 HIV RNA Post Number Analyzed 1 participants
51
Patient #6 HIV RNA Pre Number Analyzed 1 participants
850
Patient #6 HIV RNA Post Number Analyzed 1 participants
300
Patient #7 HIV RNA Pre Number Analyzed 1 participants
250
Patient #7 HIV RNA Post Number Analyzed 1 participants
310
2.Primary Outcome
Title Pre- and Post- Interferon Alpha on Human Immunodeficiency Virus Type 1 (HIV-1) Deoxyribonucleic Acid (DNA)
Hide Description Cell associated HIV nucleic acid levels were measured using a single copy assay, and numbers of cells were quantified using a polymerase chain reaction method that detects C-C chemokine receptor type 5 (CCR5) DNA.
Time Frame week 4 (post) compared to week 0 (pre)
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 7 participants were analyzed overall and each row of data represents each participant's analyzed data.
Arm/Group Title Interferon Treatment
Hide Arm/Group Description:

Interferon treatment

Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: # of copies of DNA/million cells
Patient #1 HIV DNA Pre Number Analyzed 1 participants
1200
Patient #1 HIV DNA Post Number Analyzed 1 participants
790
Patient #2 HIV DNA Pre Number Analyzed 1 participants
150
Patient #2 HIV DNA Post Number Analyzed 1 participants
150
Patient #3 HIV DNA Pre Number Analyzed 1 participants
660
Patient #3 HIV DNA Post Number Analyzed 1 participants
500
Patient #4 HIV DNA Pre Number Analyzed 1 participants
400
Patient #4 HIV DNA Post Number Analyzed 1 participants
310
Patient #5 HIV DNA Pre Number Analyzed 1 participants
10
Patient #5 HIV DNA Post Number Analyzed 1 participants
19
Patient #6 HIV DNA Pre Number Analyzed 1 participants
520
Patient #6 HIV DNA Post Number Analyzed 1 participants
420
Patient #7 HIV DNA Pre Number Analyzed 1 participants
390
Patient #7 HIV DNA Post Number Analyzed 1 participants
460
3.Secondary Outcome
Title Fold Change in Ribonucleic Acid (RNA) and Deoxyribonucleic Acid (DNA) in Human Immunodeficiency Virus Type 1 (HIV-1) Genetic Variation in Individuals Undergoing Interferon Therapy
Time Frame week 4 (post) and week 0 (pre)
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 7 participants were analyzed overall and each row of data represents each participant's analyzed data.
Arm/Group Title Interferon Treatment
Hide Arm/Group Description:

Interferon treatment

Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: fold change
Patient #1 Number Analyzed 1 participants
0.408
Patient #2 Number Analyzed 1 participants
1.44
Patient #3 Number Analyzed 1 participants
0.684
Patient #4 Number Analyzed 1 participants
1.12
Patient #5 Number Analyzed 1 participants
2.24
Patient #6 Number Analyzed 1 participants
4.37
Patient #7 Number Analyzed 1 participants
1.05
4.Secondary Outcome
Title Pre-and Post- Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) in HIV-infected Individuals
Hide Description The outcome measure is copies of HIV RNA per ml of plasma. HIV RNA levels are measured using a polymerase chain reaction method.
Time Frame week 4 (post) compared to week 0 (pre)
Hide Outcome Measure Data
Hide Analysis Population Description
Median and standard deviation were calculated using multiple samples from each participant. On patient #5 there was an error with the machine when the samples were ran and they did not have any other samples to rerun it. Patient #5 will not be analyzed since there is no more samples.
Arm/Group Title Interferon Treatment
Hide Arm/Group Description:

Interferon treatment

Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b

Overall Number of Participants Analyzed 6
Median (Standard Deviation)
Unit of Measure: copies/ml
Patient #1 Pre Number Analyzed 1 participants
0.7  (0.8)
Patient #1 Post Number Analyzed 1 participants
3.8  (1.9)
Patient #2 Pre Number Analyzed 1 participants
0.2  (0.4)
Patient #2 Post Number Analyzed 1 participants
.02  (0)
Patient #3 Pre Number Analyzed 1 participants
3.8  (1.9)
Patient #3 Post Number Analyzed 1 participants
0.8  (0.9)
Patient #4 Pre Number Analyzed 1 participants
.02  (0)
Patient #4 Post Number Analyzed 1 participants
1.5  (1.2)
Patient #6 Pre Number Analyzed 1 participants
1.3  (1.1)
Patient #6 Post Number Analyzed 1 participants
0.36  (0.6)
Patient #7 Pre Number Analyzed 1 participants
9.1  (3.0)
Patient #7 Post Number Analyzed 1 participants
8.8  (3.0)
5.Secondary Outcome
Title Count of Participants With Serious and Non-serious Adverse Events Assessed by the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adult Adverse Events.
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adult Adverse Events for severity (mild/moderate/severe), expectedness (expected/unexpected), and relatedness to study drug (definitely, probably, possibly, unlikely, or unrelated).
Time Frame Date consent signed to date off study, approximately 66 months and 2 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon Treatment
Hide Arm/Group Description:

Interferon treatment

Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b

Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
7
 100.0%
Time Frame The adverse events were collected from date of consent to date off study, approximately 66 months and 2 days.
Adverse Event Reporting Description Adverse events were graded according to the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading Adults Adverse Events.
 
Arm/Group Title Interferon Treatment
Hide Arm/Group Description

Interferon treatment

Pegylated Interferon Alpha 2b (PEGINTRON): pegylated preparation of interferon alpha 2b

All-Cause Mortality
Interferon Treatment
Affected / at Risk (%)
Total   0/7 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Interferon Treatment
Affected / at Risk (%) # Events
Total   1/7 (14.29%)    
Injury, poisoning and procedural complications   
Craniocerebral injury  1  1/7 (14.29%)  1
1
Term from vocabulary, DAIDS AE Grading v21
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Interferon Treatment
Affected / at Risk (%) # Events
Total   7/7 (100.00%)    
Gastrointestinal disorders   
Abdominal pain  1  2/7 (28.57%)  3
Diarrhea  1  2/7 (28.57%)  3
Dry mouth  1  2/7 (28.57%)  4
Gastroesophageal reflux disease  1  1/7 (14.29%)  1
Nausea  1  2/7 (28.57%)  2
Vomiting  1  2/7 (28.57%)  2
General disorders   
Chills  1  1/7 (14.29%)  1
Fatigue  1  3/7 (42.86%)  7
Pain  1  1/7 (14.29%)  1
Pyrexia  1  4/7 (57.14%)  6
Immune system disorders   
Hypersensitivity  1  1/7 (14.29%)  1
Injury, poisoning and procedural complications   
Injection site erythema  1  1/7 (14.29%)  1
Injection site reaction  1  2/7 (28.57%)  3
Injury  1  1/7 (14.29%)  1
Investigations   
Alanine aminotransferase increased  1  2/7 (28.57%)  4
Aspartate aminotransferase increased  1  2/7 (28.57%)  4
Blood cholesterol increased  1  1/7 (14.29%)  1
Hemoglobin decreased  1  1/7 (14.29%)  1
Neutrophil count decreased  1  5/7 (71.43%)  10
Platelet count decreased  1  2/7 (28.57%)  4
Prothrombin time prolonged  1  1/7 (14.29%)  1
White blood cell count decreased  1  2/7 (28.57%)  2
Metabolism and nutrition disorders   
Hyperglycemia  1  2/7 (28.57%)  7
Hyperkalemia  1  1/7 (14.29%)  1
Hypocalcemia  1  2/7 (28.57%)  2
Hypokalaemia  1  2/7 (28.57%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/7 (42.86%)  7
Myalgia  1  5/7 (71.43%)  12
Nervous system disorders   
Headache  1  2/7 (28.57%)  7
Psychiatric disorders   
Insomnia  1  1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders   
Nasal congestion  1  1/7 (14.29%)  2
Oropharyngeal pain  1  1/7 (14.29%)  1
Productive cough  1  1/7 (14.29%)  1
Rhinorrhea  1  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Dermatophytosis  1  1/7 (14.29%)  1
Night sweats  1  1/7 (14.29%)  1
Vascular disorders   
Blood pressure increased  1  1/7 (14.29%)  1
1
Term from vocabulary, DAIDS AE Grading v21
Indicates events were collected by systematic assessment
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. Frank Maldarelli
Organization: National Cancer Institute
Phone: 301- 846-5611
Responsible Party: Frank Maldarelli, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01295515     History of Changes
Other Study ID Numbers: 110057
11-I-0057 ( Other Identifier: NIH )
First Submitted: February 11, 2011
First Posted: February 14, 2011
Results First Submitted: December 19, 2018
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019