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HIV InfectionsPhase 2NCT00078442

Safety and Tolerability of Pegylated Interferon (PEG-IFN) Alfa-2a in HIV Infected People

A Phase 2 study testing Pegylated interferon alfa-2a in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Pegylated interferon alfa-2a
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesUnited States
Study dates
May 2006to Jan 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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
  • Evidence of chronic pulmonary disease
  • Severe eye problems due to diabetes, hypertension, cytomegalovirus infection, or macular degeneration
  • History of major organ transplantation with an existing functional graft
  • History or other evidence of severe illness, cancer, or other conditions that would make the patient unsuitable for the study
  • Hemoglobin abnormalities or any other cause of or tendency for breakdown of red blood cells
  • Any medical condition that would prevent successful completion of the study
  • Use of certain medications
  • Pregnant or breastfeeding

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Northwestern University

    Chicago, Illinois, 60611-3015

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of California, Davis Medical Center

    Sacramento, California, 95814

Other trials in United States

About this study

Official title: A Phase II Open-Label Pilot Trial of the Antiretroviral Activity, Safety, and Tolerability of Pegylated Interferon Alfa-2A (40KD) [PegasysTM] in HIV-1 Infected Subjects

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.

Read the detailed description

IFN is an immune response enhancer and is produced in the body in response to viral infection. PEG-IFN may have less harmful side effects than non-pegylated IFN. Recombinant PEG-IFN alfa-2a is a synthetic version of IFN and is used in hepatitis C virus treatment. PEG-IFN alfa-2a has demonstrated potentially useful antiviral properties in HIV treatment; however, due to the high doses that must be administered to maintain viral suppression, toxicity (especially to the blood) is a concern. This study will evaluate the safety, tolerability, and antiretroviral activity of PEG-IFN alfa-2a in HIV infected patients who have received ART in the past but are currently off ART or who are ART naive.

The study will last 18 weeks. 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. Physical exams will be performed weekly. Blood collection to monitor viral load, PEG-IFN alfa-2a serum levels, and CD4 and CD8 counts will be conducted at selected weeks during the study. Filgrastim will be given to patients who exhibit neutropenic toxicity.

Conditions
HIV Infections
Being tested
Pegylated interferon alfa-2a
Keywords
Treatment Experienced, Treatment Interruption, Treatment Naive
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pegylated interferon alfa-2aDrug

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

Study groups in NCT00078442
Study groupRoleWhat they receive
1ExperimentalParticipants 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.
Receives: Drug: Pegylated interferon alfa-2a

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CD4 count

    Measured: Throughout study

  2. CD8 count

    Measured: Throughout study

  3. Laboratory and clinical adverse effects

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2004 (estimated)
  2. Study startMay 2006
  3. Primary completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00078442
Sponsor's protocol ID
ACTG A5192
Other IDs
DAIDS-ES ID 10013
Status last verified
Aug 2009
First submitted
25 Feb 2004
Last updated
7 Aug 2009
Results posted
No

Publications

  • 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.

    PubMed 11693314

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

    PubMed 14556604

  • 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.

    PubMed 11504966

  • 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.

    PubMed 14513386

  • 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.

    PubMed 14499239

  • 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.

    PubMed 20420510

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegylated interferon alfa-2a in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CD4 count (time frame: Throughout study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00078442, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2009.

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