Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected With HIV
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT00006441
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 398
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Aldesleukin Patients beginning IL-2 treatment regimens after 4 weeks of study B Nelfinavir mesylate Patients beginning IL-2 treatment after some delay based on specified criteria B Aldesleukin Patients beginning IL-2 treatment after some delay based on specified criteria A Lamivudine/Zidovudine Patients beginning IL-2 treatment regimens after 4 weeks of study A Nelfinavir mesylate Patients beginning IL-2 treatment regimens after 4 weeks of study B Lamivudine/Zidovudine Patients beginning IL-2 treatment after some delay based on specified criteria
- Primary Outcome Measures
Name Time Method 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 Throughout study 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. Throughout study 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. Throughout study 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. Throughout study
- Secondary Outcome Measures
Name Time Method 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. Throughout study
Trial Locations
- Locations (2)
University of Alabama- Birmingham
🇺🇸Birmingham, Alabama, United States
Rick Hecht
🇺🇸San Francisco, California, United States