Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected With HIV
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Purpose
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 |
|---|---|
|
HIV Infections |
Drug: Lamivudine/Zidovudine Drug: Nelfinavir mesylate Drug: Aldesleukin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- To evaluate the dynamics of HIV in different tissue compartments of maximally suppressive antiretroviral (ART) medications with IL-2 influences, viral pathogenesis and immune responses to HIV infection. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- To determine the patterns of immunologic activation as measured by cell surface marker levels, soluble and cell-associated cytokines when persons with acute or early HIV infection are treated with ART and IL-2. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- To examine whether the extent of CD8+ cell antiviral activity as measured by non-cytotoxic and cytotoxic responses affects the kinetics of viral replication and viral load in blood plasma. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- To determine whether a broad cellular immune response to HIV infection, measured by T cell repertoire, cytotoxic T cell lymphocyte function and CD4 T helper function correlates with the patterns of cellular immune antiviral responses [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- To follow a cohort of HIV negative individuals that tested with the Options Project to use as a comparison group with the HIV positive individuals enrolling in this protocol. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 398 |
| Study Start Date: | February 2003 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Patients beginning IL-2 treatment regimens after 4 weeks of study
|
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.
Other Name: Combivir
Drug: Nelfinavir mesylate
1250 mg twice daily for 104 weeks.
Other Name: NFV
Drug: Aldesleukin
7.5 million units twice daily. Treatment will last until conclusion of study.
Other Name: IL-2
|
|
Active Comparator: B
Patients beginning IL-2 treatment after some delay based on specified criteria
|
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.
Other Name: Combivir
Drug: Nelfinavir mesylate
1250 mg twice daily for 104 weeks.
Other Name: NFV
Drug: Aldesleukin
7.5 million units twice daily. Treatment will last until conclusion of study.
Other Name: IL-2
|
Detailed Description:
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.
Eligibility| 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:
- Have recent HIV infection.
- Are available for follow-up for at least 96 weeks.
- Are at least 18 years old.
- Use a barrier method of birth control.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a condition such as Epstein-Barr virus, CMV mononucleosis syndrome, or acute streptococcal pharyngitis.
- Have taken anti-HIV therapy for over 4 weeks.
- Have or have had cancer requiring chemotherapy or radiation therapy within 1 month of study entry and have not yet recovered from the effects.
- Abuse alcohol and other drugs.
- Are pregnant.
- Have a condition which interferes with intestinal absorption, such as severe diarrhea.
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Rona Siskind, DAIDS |
| ClinicalTrials.gov Identifier: | NCT00006441 History of Changes |
| Other Study ID Numbers: | AI-01-001, AIEDRP AI-01-001 |
| Study First Received: | November 3, 2000 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
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 |
Additional relevant MeSH terms:
|
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 Aldesleukin Interleukin-2 Zidovudine Lamivudine |
Reverse Transcriptase Inhibitors Lamivudine, zidovudine drug combination Nelfinavir HIV Protease Inhibitors Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013