NCT00078442

Brief Summary

Recombinant interferon (IFN) may be useful in the treatment of HIV. However, the high doses of IFN necessary to keep HIV under control limit its use due to toxic side effects. The purpose of this study is to test the safety and tolerability of weekly recombinant pegylated interferon (PEG-IFN) alfa-2a in HIV infected people who are currently on antiretroviral therapy (ART) interruption or who have not started taking anti-HIV drugs.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2 hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2004

Completed
2.2 years until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

8 months

First QC Date

February 25, 2004

Last Update Submit

August 6, 2009

Conditions

HIV Infections

Keywords

Treatment ExperiencedTreatment InterruptionTreatment Naive

Outcome Measures

Primary Outcomes (3)

  • CD4 count

    Throughout study

  • CD8 count

    Throughout study

  • Laboratory and clinical adverse effects

    Throughout study

Study Arms (1)

1

EXPERIMENTAL

Participants will receive weekly injections of 180 mcg PEG-IFN alfa-2a at the clinic for 12 weeks. After Week 12, participants will be followed off-treatment until Week 18.

Drug: Pegylated interferon alfa-2a

Interventions

Pegylated interferon alfa-2aDRUG

Recombinant PEG-IFN alfa-2a is a synthetic version of IFN and is used in hepatitis C virus treatment

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected
  • CD4 count of 300 cells/ml or greater within 30 days of study entry
  • HIV viral load of 5000 copies/ml or greater within 30 days of study entry
  • Received ART previously but have currently interrupted treatment within 12 weeks prior to study entry OR ART naive
  • Willing to delay initiation or re-initiation of antiretroviral medications for the duration of the study
  • Agree to use acceptable forms of contraception

You may not qualify if:

  • Previous use of interferon alfa
  • Known allergy or sensitivity to PEG-IFN alfa-2a or its formulation
  • Active drug or alcohol abuse that would interfere with the study
  • Acute therapy for a serious infection within 30 days of study entry
  • Use of non-protocol-specified immunomodulatory therapy within 60 days of study entry
  • Active immunization within 30 days of study entry
  • History of severe psychiatric disease such as major depression, suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to psychiatric disease
  • History of poorly controlled thyroid disease, including history of elevated thyroid stimulating hormone (TSH) levels with elevated antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
  • History of clinically significant heart disease that could be worsened by acute anemia
  • History of severe seizure disorder or current anticonvulsant use
  • Hepatitis C antibody positive within 60 days prior to study entry
  • Hepatitis B surface antigen positive within 60 days prior to study entry
  • Known sensitivity to E. coli derived products, such as filgrastim
  • Any past evidence of chronic liver disease
  • Any past or current evidence of immunologically-mediated disease
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, Davis Medical Center

Sacramento, California, 95814, United States

Location

Northwestern University

Chicago, Illinois, 60611-3015, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (6)

  • Bain VG. Effect of HCV viral dynamics on treatment design: lessons learned from HIV. Am J Gastroenterol. 2001 Oct;96(10):2818-28. doi: 10.1111/j.1572-0241.2001.04234.x.

    PMID: 11693314BACKGROUND

  • Dwyer JT, Paul SM. HIV and hepatitis C co-infection. N J Med. 2003 Sep;100(9 Suppl):50-4; quiz 77-8.

    PMID: 14556604BACKGROUND

  • Emilie D, Burgard M, Lascoux-Combe C, Laughlin M, Krzysiek R, Pignon C, Rudent A, Molina JM, Livrozet JM, Souala F, Chene G, Grangeot-Keros L, Galanaud P, Sereni D, Rouzioux C; Primoferon A Study Group. Early control of HIV replication in primary HIV-1 infection treated with antiretroviral drugs and pegylated IFN alpha: results from the Primoferon A (ANRS 086) Study. AIDS. 2001 Jul 27;15(11):1435-7. doi: 10.1097/00002030-200107270-00014.

    PMID: 11504966BACKGROUND

  • Kawakami K. Promising immunotherapies with Th1-related cytokines against infectious diseases. J Infect Chemother. 2003 Sep;9(3):201-9. doi: 10.1007/s10156-003-0263-5.

    PMID: 14513386BACKGROUND

  • Levy JA, Scott I, Mackewicz C. Protection from HIV/AIDS: the importance of innate immunity. Clin Immunol. 2003 Sep;108(3):167-74. doi: 10.1016/s1521-6616(03)00178-5. No abstract available.

    PMID: 14499239BACKGROUND

  • Asmuth DM, Murphy RL, Rosenkranz SL, Lertora JJ, Kottilil S, Cramer Y, Chan ES, Schooley RT, Rinaldo CR, Thielman N, Li XD, Wahl SM, Shore J, Janik J, Lempicki RA, Simpson Y, Pollard RB; AIDS Clinical Trials Group A5192 Team. Safety, tolerability, and mechanisms of antiretroviral activity of pegylated interferon Alfa-2a in HIV-1-monoinfected participants: a phase II clinical trial. J Infect Dis. 2010 Jun 1;201(11):1686-96. doi: 10.1086/652420.

    PMID: 20420510DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • David Asmuth, MD

    Division of Infectious and Immunologic Diseases, University of California, Davis Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

February 25, 2004

First Posted

February 26, 2004

Study Start

May 1, 2006

Primary Completion

January 1, 2007

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

US(3)