Advertisement

Topics

Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients

2014-08-27 03:59:46 | BioPortfolio

Summary

The purpose of this study is to find out if the immune systems of HIV-positive patients can be improved by treatment with anti-HIV medications plus interleukin-2 (IL-2) in the early stages of HIV infection.

IL-2 is a protein found naturally in the blood that can help boost the immune system. HIV spreads throughout the body by invading CD4 cells, which are cells of the immune system that fight infection. Doctors hope that adding IL-2 to a current anti-HIV drug combination can help restore the CD4 cell count and the immune functions. This study will look at how the HIV virus acts during the early stages of HIV infection, how the immune system responds to HIV, and what impact early treatment with anti-HIV medications has on the course of HIV infection.

Description

At the time of initial HIV infection, CD4 cells are susceptible to infection, and the virus infects many T cells during the first 4 to 6 weeks. Many of these infected cells subsequently maintain the virus in a latent state. Immune reconstitution with daily low-dose IL-2 therapy is intended to correct or improve the deficiency in CD4 cells, while maintaining a high frequency of CD8+ HIV-specific CTL and increasing natural killer (NK) cells. After a year of HAART plus IL-2, it may be possible to discontinue HAART while maintaining IL-2 stimulatory therapy, and the immune reactivity repaired and stimulated by IL-2 should be able to contain the virus and maintain latency.

Patients are randomized to add IL-2 to their current HAART regimen or simply to remain on their current HAART regimen. IL-2 therapy is initiated at Month 3 of HAART. IL-2 is injected subcutaneously daily for 9 months, in addition to HAART. After completion of this 1-year treatment period, patients are evaluated for discontinuation of HAART. Patients with a viral load below 50 copies/ml throughout HAART plus IL-2, a CD4 count of at least 500 cells/mm3, and no onset of opportunistic infections may have HAART discontinued and IL-2 continued as monotherapy for an additional 6 months. After completing 6 months of IL-2 monotherapy, eligible patients may have IL-2 therapy discontinued.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

HIV Infections

Intervention

Aldesleukin, HAART

Location

Johns Hopkins Hosp
Baltimore
Maryland
United States
21205

Status

Recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:46-0400

Clinical Trials [484 Associated Clinical Trials listed on BioPortfolio]

Examining Benefits of HAART Continuation in Postpartum Mothers

The purpose of this study is to see if pregnant women receiving highly active antiretroviral treatment (HAART) to prevent mother-to-child transmission of HIV will be healthier if, after de...

Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People

The purpose of this study is to determine the effect of short cycles of recombinant interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in HIV infected ...

Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients

The purpose of this study is to assess the safety of GX-12 gene therapy combined with HAART in the HIV-1 infected patients and to investigate the efficacy with the value of plasma viral lo...

Treatment With Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328

This study examines the long-term effects of interleukin-2 (IL-2) in combination with anti-HIV drugs, or highly active antiretroviral therapy (HAART). The purpose of this study is to see i...

Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients

To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin ( interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To compare the ef...

PubMed Articles [3441 Associated PubMed Articles listed on BioPortfolio]

Evaluation of Epstein-Barr Virus Salivary Shedding in HIV/AIDS Patients and HAART Use: A Retrospective Cohort Study.

Little data is available on the evaluation of the occurrence rates of Epstein-Barr virus (EBV) in saliva and relationship with highly active antiretroviral therapy (HAART) use in HIV/AIDS patients in ...

Inequalities in HAART uptake and differential survival according to exposure category in Rio de Janeiro, Brazil.

Despite substantial improvement in prognosis and quality of life among people living with HIV/AIDS (PLWHA) in Brazil, inequalities in access to treatment remain. We assessed the impact of these inequa...

Highly active antiretroviral therapy adherence among perinatally infected HIV adolescents at a teaching hospital in Ghana.

Increased accessibility to Antiretroviral Therapy (ART) has resulted in the decline of deaths among children with Perinatally Infected Human Immunodeficiency Virus (PIHIV). Their adherence to Highly A...

Rhodotorula species infections in humans: a systematic review.

Fungal infections by Rhodotorula species are increasingly reported in the literature and consist of bloodstream infections, especially in patients with central venous catheters (CVC), as well as centr...

A New Scoring System to Predict Blood Stream Infections in Patients with Complicated Intra-Abdominal Infections: Experience from a Tertiary Referral Hospital in China.

This purpose of this study was to investigate the effects of blood stream infections (BSIs) on the prognosis of patients with complicated intra-abdominal infections (IAIs) and to make predictions base...

Medical and Biotech [MESH] Definitions

Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.

Viral infections of the leptomeninges and subarachnoid space. TOGAVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; RUBELLA; BUNYAVIRIDAE INFECTIONS; ORBIVIRUS infections; PICORNAVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RHABDOVIRIDAE INFECTIONS; ARENAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; JC VIRUS infections; and RETROVIRIDAE INFECTIONS may cause this form of meningitis. Clinical manifestations include fever, headache, neck pain, vomiting, PHOTOPHOBIA, and signs of meningeal irritation. (From Joynt, Clinical Neurology, 1996, Ch26, pp1-3)

Infections with viruses of the family PARAMYXOVIRIDAE. This includes MORBILLIVIRUS INFECTIONS; RESPIROVIRUS INFECTIONS; PNEUMOVIRUS INFECTIONS; HENIPAVIRUS INFECTIONS; AVULAVIRUS INFECTIONS; and RUBULAVIRUS INFECTIONS.

Exuberant inflammatory response towards previously undiagnosed or incubating opportunistic pathogens. It is frequently seen in AIDS patients following HAART.

Pathogenic infections of the brain, spinal cord, and meninges. DNA VIRUS INFECTIONS; RNA VIRUS INFECTIONS; BACTERIAL INFECTIONS; MYCOPLASMA INFECTIONS; SPIROCHAETALES INFECTIONS; fungal infections; PROTOZOAN INFECTIONS; HELMINTHIASIS; and PRION DISEASES may involve the central nervous system as a primary or secondary process.

More From BioPortfolio on "Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Human Immuno Deficiency Virus (HIV)
Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...

AIDS and HIV
AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...


Searches Linking to this Trial