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Effectiveness of Zidovudine vs. Zidovudine Plus Alpha Interferon vs. Interferon for Treatment of HIV

2014-08-27 03:13:39 | BioPortfolio

Summary

This study will compare the effectiveness of zidovudine (AZT) alone vs. zidovudine plus interferon (IFN) vs. interferon alone in reducing HIV viral load, lessening immune system deterioration, and increasing the time to development of the first opportunistic infection in HIV-infected patients.

HIV-infected persons 18 years of age and older with a T4 lymphocyte count of 500/mm3 or more and no current opportunistic infections may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests, chest X-ray, electrocardiogram, urinalysis, and, for patients with Kaposi's sarcoma lesions, measurement, photographs, and biopsy of lesions.

Patients will be assigned to receive treatment with either zidovudine alone, zidovudine plus interferon or interferon alone. They will continue treatment until one of the following occurs:

- Unacceptable side effects, despite dose modifications

- Development of an opportunistic infection

- Decrease in CD4 count by 20 percent or to an absolute count of less than 200/mm3

- Rapid progression of Kaposi's sarcoma lesions, requiring alternative therapy

- A decision is made to terminate the study

Patients will be followed long term for viral load, immune function, development of opportunistic infections, disease progression, and survival.

Description

Initial Study: Three Arm (Interventional) Study

This phase III study will evaluate the relative efficacy of zidovudine (AZT) vs. AZT + alpha interferon (IFN) vs. IFN in increasing time to first opportunistic infection, reducing HIV viremia, and lessening immune system deterioration in HIV-infected persons. For the AZT-alone arm, AZT dosing will be the standard regimen of 200 mg q4h. Persons on the AZT + IFN combination arm will receive AZT 100 mg q4h with IFN beginning at 1 million units qd, escalating up to 2.5 million units at 2 weeks, then in increments of 2.5 million units every 2 weeks. Patients on the IFN-alone arm will begin therapy at 5 million units qd and escalate in 2.5 million unit increments every 2 weeks, unless escalations are precluded by toxicity. Patients who have evidence of HIV infection and CD4 count greater than or equal to 500 will be randomized to one of the three treatment groups. Patients will continue to be treated with their assigned medication until intolerable toxicity, opportunistic infection, or progressive Kaposi's sarcoma develops, or CD4 count declines to less than 200/mm(3).

Long-Term Follow-up: Extension Phase (Natural History Study)

This protocol was initiated in 1988 and was the first study to evaluate early intervention with antiretroviral agents in patients with HIV infection. Research medication has not been administered since January of 1997, but this cohort still serves as an important source of data regarding the long-term medical course of patients who have received an early intervention for HIV infection. Participants will remain in long-term follow-up in order to provide valuable information regarding the long-term outcomes of patients receiving anti-HIV treatment, and to provide information on the long-term consequences of therapy. Hence, this study is analogous to a longitudinal natural history study.

Study Design

Primary Purpose: Treatment

Conditions

HIV

Intervention

Ziodovudine and Alpha Interferon

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda
Maryland
United States
20892

Status

Active, not recruiting

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:39-0400

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Medical and Biotech [MESH] Definitions

Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).

A ubiquitously expressed heterodimeric receptor that is specific for both INTERFERON-ALPHA and INTERFERON-BETA. It is composed of two subunits referred to as IFNAR1 and IFNAR2. The IFNAR2 subunit is believed to serve as the ligand-binding chain; however both chains are required for signal transduction. The interferon alpha-beta receptor signals through the action of JANUS KINASES such as the TYK2 KINASE.

An interferon regulatory factor that binds upstream TRANSCRIPTIONAL REGULATORY ELEMENTS in the GENES for INTERFERON-ALPHA and INTERFERON-BETA. It functions as a transcriptional activator for the INTERFERON TYPE I genes.

A DEAD box RNA helicase that contains two N-terminal CASPASE ACTIVATION AND RECRUITMENT DOMAINS. It functions as a sensor of viral NUCLEIC ACIDS such as DOUBLE-STRANDED RNA and activates the INNATE IMMUNE RESPONSE by inducing the expression of INTERFERON-ALPHA and INTERFERON-BETA. It may also regulate cell growth and APOPTOSIS.

A multimeric complex that functions as a ligand-dependent transcription factor. ISGF3 is assembled in the CYTOPLASM and translocated to the CELL NUCLEUS in response to INTERFERON signaling. It consists of ISGF3-GAMMA and ISGF3-ALPHA, and it regulates expression of many interferon-responsive GENES.

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