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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT01295515 |
Purpose
Background:
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:
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: Interferon Alpha 2b |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Interferon Alpha 2b Intensification on HIV-1 Residual Viremia in Individuals Suppressed on Antiretroviral Therapy |
| Estimated Enrollment: | 45 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
As a result of combination antiretroviral therapy (ART), morbidity and mortality from acquired immunodeficiency syndrome has declined significantly in the past 12 years, at least in developed countries. Human immunodeficiency virus type 1 (HIV-1) infected individuals now live longer, but must undergo continuous therapy that has substantial consequences on quality of life.
ART suppresses HIV-1 viremia below the limits of detection in current commercial assays (50 copies/mL plasma). Although therapy is not immediately curative, previous studies were optimistic, suggesting prolonged duration of suppressive therapy could result in eventual viral eradication. More recent data suggest, however, that HIV-1 RNA persists even after prolonged suppressive therapy. The origin of this residual viremia is yet not defined but data from several sources, including our own, indicate that persistent viremia may be the product of viral genome production from chronically infected long-lived reservoirs, and not from new ongoing cycles of HIV-1 infection.
Antiretrovirals are extremely active against replicating cells, and can thus successfully stop viral replication, but have no effect on long-lived viral reservoirs of cells already infected with HIV-1 at the time antiretroviral therapy is initiated. As a result, new strategies may be necessary to reduce or eradicate long-lived reservoirs.
Interferon alpha is a natural cytokine with antiviral activity. Prior to the introduction of antiretroviral therapy, several studies demonstrated modest effect of interferon alpha in HIV-1 viremia in active cycles of infection in infected individuals. Interferon alpha was also effective in vitro in decreasing virus production from cells chronically infected with HIV-1. With the introduction of potent antiretroviral therapy, interferon was not developed as a direct anti-HIV drug. Interferon alpha is relatively effective in therapy of hepatitis C virus (HCV) infection, and has been used in HIV-1/HCV coinfected individuals. Recently, Kottilil and coworkers in the Laboratory of Immunoregulation NIAID have shown a decrease in HIV-1 RNA levels in HCV coinfected participants treated with pegylated interferon alpha and ribavirin. In stored samples from that study, we conducted a retrospective trial on samples from participants with HIV-1 RNA levels of < 50 copies/mL, showing a further reduction in residual viremia using an ultrasensitive Single Copy Assay (SCA) developed in our laboratory.
In this protocol we will conduct a prospective, non-randomized, single arm, pilot study to investigate the effect of pegylated interferon alpha 2b on HIV-1 RNA levels as an additional drug in participants undergoing suppressive antiretroviral therapy with viral RNA levels suppressed to less than 50 copies/mL plasma. We will determine whether interferon alpha therapy will reduce residual viremia in participants on suppressive ART, which will expand our understanding of persistent low-level viremia in HIV-1 infected individuals.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
To be eligible for study participation, a volunteer must satisfy all of the following inclusion criteria:
Laboratory values at pre-entry visit within 14 days prior to enrollment:
EXCLUSION CRITERIA:
A volunteer will be ineligible to participate in this study if any of the following criteria are met:
Contacts and Locations| Contact: Laura A Heytens | (301) 435-8003 | heytensl@mail.nih.gov |
| Contact: Frank Maldarelli, M.D. | (301) 435-8019 | fmalli@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| Principal Investigator: | Frank Maldarelli, M.D. | National Cancer Institute (NCI) |
More Information
| Responsible Party: | Frank Maldarelli, M.D./National Cancer Institute, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT01295515 History of Changes |
| Other Study ID Numbers: | 110057, 11-I-0057 |
| Study First Received: | February 11, 2011 |
| Last Updated: | March 20, 2012 |
| Health Authority: | United States: Federal Government |
|
HIV Infection Replication Antiretroviral |
Interferon Reservoirs HIV |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Interferon-alpha Interferon Alfa-2a |
Interferon Alfa-2b Interferons Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |