Interferon Alpha 2b Intensification in HIV-Positive Individuals on Antiretroviral Therapy
Status:
Completed
Trial end date:
2017-05-31
Target enrollment:
Participant gender:
Summary
Background:
- Antiretroviral therapy (ART) has been able to improve the lifespan of individuals
infected with human immunodeficiency virus type 1 (HIV-1), but ART requires continuous
treatment that has substantial consequences on quality of life. Recent research is
attempting to determine whether this persistent infection stems from a low-level
infection where new cells are continually infected with HIV, or from cells that live for
a long time after infection. ART is very active against the virus in new cells, but has
no effect on long-lived cells that are already infected with HIV-1 at the start of ART.
As a result, new strategies may be necessary to reduce or eradicate these 'reservoir'
cells.
- Interferon is a natural substance made by the body to combat virus infections, and can
be made as an injectable drug known as PEGINTRON. Researchers are interested in
determining whether PEGINTRON therapy will also reduce the residual low levels of HIV in
patients who are already taking ART.
Objectives:
- To evaluate the effectiveness of PEGINTRON injections on HIV levels in participants
currently undergoing antiretroviral therapy.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with HIV, are currently
undergoing antiretroviral therapy, and have maintained HIV virus blood counts that are not
detectable by current commercial tests for at least 12 months before the start of the study.
Design:
- This study will involve separate screening and treatment processes.
- Participants will be screened with a physical examination and medical history, including
blood and urine samples. The screening analysis to determine study eligibility will take
several weeks. Participants will have apheresis to provide sufficient numbers of blood
cells for evaluation by the study researchers.
- Eligible participants will begin a 4-week course of PEGINTRON injections using the
standard dose of PEGINTRON that is approved for treatment of chronic hepatitis C.
Participants will have weekly injections and have frequent blood tests to measure HIV
virus levels.
- Participants who experience problems in maintaining safe numbers of white blood cells
during the study may receive injections of filgrastim to increase their white blood cell
count.
- After the 4 weeks of treatment, participants will return for additional blood tests on
study days 28, 35, 42, 49, 56, and 84, and Weeks 16, 24, 36, and 48 (i.e., through the
end of 1 year after the start of the study).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Cancer Institute (NCI) National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)