Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	HIV Infections
Interventions:	Drug: Pegylated Interferon-alpha 2a, 180 mcg/week sc; Drug: Pegylated Interferon-alpha 2a, 90 mcg/week sc

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
locations: medical clinics (Hospital of the University of Pennsylvania, Jonathan Lax clinic, Drexel University Hospital) Recruitment period: may 8, 2008 to May 27, 2010

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
subjects were randomized to the pegasys dose of 180 or 90 mcg/week four weeks after enrollment (week 0: eligibility determination; week 4: enrollment; week 8: randomization and treatment initiation; week 13: ART interruption; week 25: primary endpoint; week 37: secondary endpoints)

Reporting Groups

	Description
Pegasys 180 mcg/Week	ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
Pegasys 90 mcg/Week	ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints

Participant Flow:   Overall Study

	Pegasys 180 mcg/Week	Pegasys 90 mcg/Week
STARTED	12	11
COMPLETED	10	10
NOT COMPLETED	2	1
Withdrawal by Subject	1	1
Lost to Follow-up	1	0

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Pegasys 180 mcg/Week	ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
Pegasys 90 mcg/Week	ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
Total	Total of all reporting groups

Baseline Measures

	Pegasys 180 mcg/Week	Pegasys 90 mcg/Week	Total
Overall Participants Analyzed; [Units: Participants]	12	11	23
Age; [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	12	11	23
>=65 years	0	0	0
Age; [Units: Years]; Median (Inter-Quartile Range)
Age	45.5; (42.8 to 48.5)	44; (32 to 49.5)	45; (40.5 to 49.5)
Gender; [Units: Participants]
Female	3	1	4
Male	9	10	19
Region of Enrollment; [Units: Participants]
United States	12	11	23

  Outcome Measures

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1. Primary:

HIV Viral Load < 400 Copies/ml [ Time Frame: 12 weeks ]

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2. Secondary:

HIV Viral Load < 48 Copies/ml [ Time Frame: 12 weeks ]

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3. Secondary:

HIV Viral Load < 400 Copies/ml [ Time Frame: 24 weeks ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The follwing limitations of this study should be noted: Small number of participants enrolled; Lack of a control arm interrupting ART without immunotherapy

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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: Luis Montaner
Organization: the Wistar Institute
phone: 215 898 3934
e-mail: montaner@mail.wistar.org

Publications of Results:

Azzoni L, Foulkes AS, Papasavvas E, Mexas AM, Lynn KM, Mounzer K, Tebas P, Jacobson JM, Frank I, Busch MP, Deeks SG, Carrington M, O'Doherty U, Kostman J, Montaner LJ. Pegylated Interferon alfa-2a monotherapy results in suppression of HIV type 1 replication and decreased cell-associated HIV DNA integration. J Infect Dis. 2013 Jan 15;207(2):213-22. doi: 10.1093/infdis/jis663. Epub 2012 Oct 26.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chitre AS, Kattah MG, Rosli YY, Pao M, Deswal M, Deeks SG, Hunt PW, Abdel-Mohsen M, Montaner LJ, Kim CC, Ma A, Somsouk M, McCune JM. A20 upregulation during treated HIV disease is associated with intestinal epithelial cell recovery and function. PLoS Pathog. 2018 Mar 5;14(3):e1006806. doi: 10.1371/journal.ppat.1006806. eCollection 2018 Mar.

Responsible Party:	Luis Montaner, The Wistar Institute
ClinicalTrials.gov Identifier:	NCT00594880 History of Changes
Other Study ID Numbers:	DAIDS-ES 10401; U01AI065279 ( U.S. NIH Grant/Contract )
First Submitted:	January 4, 2008
First Posted:	January 16, 2008
Results First Submitted:	January 24, 2013
Results First Posted:	February 10, 2015
Last Update Posted:	February 10, 2015