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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Chiron Corporation Agouron Pharmaceuticals Glaxo Wellcome |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00006441 |
The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV drugs affects the course of HIV disease in patients with primary HIV infection (the time period that immediately follows infection with HIV).
After primary HIV infection, the actual infection is spread through an increasing amount of HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it is possible to reduce the amount of HIV in the body to almost undetectable levels. This study will find out if starting anti-HIV drugs during primary infection will interrupt or reduce the spread of HIV in patients' bodies.
Condition | Intervention |
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HIV Infections |
Drug: Lamivudine/Zidovudine Drug: Nelfinavir mesylate Drug: Aldesleukin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | A Single Center, Randomized Open Label Study of Initial Interleukin-2 Compared to Delayed Interleukin-2 When Added to Zidovudine, 3TC and Nelfinavir In Order to Modulate Immune Function and to Sustain Suppression of HIV-1 Replication Among Those Persons With Primary or Early HIV Infection |
Enrollment: | 398 |
Study Start Date: | February 2003 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Patients beginning IL-2 treatment regimens after 4 weeks of study
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Drug: Lamivudine/Zidovudine
300/150 mg respectively twice daily for 104 weeks. Patients who develop intolerence to AZT may use Stavudine (d4T) at a dose of 40 mg daily.
Drug: Nelfinavir mesylate
1250 mg twice daily for 104 weeks.
Drug: Aldesleukin
7.5 million units twice daily. Treatment will last until conclusion of study.
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B: Active Comparator
Patients beginning IL-2 treatment after some delay based on specified criteria
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Drug: Lamivudine/Zidovudine
300/150 mg respectively twice daily for 104 weeks. Patients who develop intolerence to AZT may use Stavudine (d4T) at a dose of 40 mg daily.
Drug: Nelfinavir mesylate
1250 mg twice daily for 104 weeks.
Drug: Aldesleukin
7.5 million units twice daily. Treatment will last until conclusion of study.
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Following initial exposure to HIV, infection is established through the rapid replication of a homogeneous strain of the virus. Preliminary studies of combination antiretroviral therapy show that it is possible to reduce circulating HIV RNA to below detectable levels at this phase. Sustained suppression of viral replication or viral eradication may be possible only before HIV has become integrated in the immune system and undergone a number of quasi species mutations. This study will assess the feasibility of interrupting the natural course of HIV infection by using antiretroviral therapy soon after initial infection.
Nelfinavir (NFV) and zidovudine/lamivudine (Combivir) treatment starts as soon as possible and at most, 7 days from the diagnosis of HIV infection, and continues for 104 weeks. After 4 weeks of therapy patients are randomized to begin receiving IL-2 therapy or to delay starting it until Week 48. Patients may choose not to receive IL-2 treatment and remain in the study. Patients have clinic visits to measure viral load every 4 weeks. At a final clinic visit, physical examinations and collection of semen, cervical fluid, blood, and saliva specimens are done. Eligible consenting patients have a tonsil biopsy. Patients are reimbursed for participation in this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, Alabama | |
University of Alabama- Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Rick Hecht | |
San Francisco, California, United States, 941102859 |
Principal Investigator: | Jay Levy |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | AIEDRP AI-01-001 |
Study First Received: | November 3, 2000 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00006441 History of Changes |
Health Authority: | United States: Federal Government |
Virus Replication HIV-1 Interleukin-2 Drug Therapy, Combination Zidovudine HIV Protease Inhibitors CD4-Positive T-Lymphocytes CD8-Positive T-Lymphocytes |
Biological Markers Lamivudine Reverse Transcriptase Inhibitors Anti-HIV Agents Nelfinavir Cytotoxicity, Immunologic Acute Infection |
Antimetabolites HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Stavudine Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors |
Virus Diseases Aldesleukin Anti-Retroviral Agents Analgesics, Non-Narcotic Interleukin-2 HIV Infections Sexually Transmitted Diseases Peripheral Nervous System Agents Analgesics Nelfinavir Retroviridae Infections |
Antimetabolites Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Sensory System Agents Therapeutic Uses |
Analgesics Nelfinavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases |