A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT00006154
- Brief Summary
The purpose of this study is to look at the effectiveness of combination anti-HIV drug therapy (with protease inhibitors \[PIs\] or without) in patients with early HIV infections. This study also looks at whether a drug called interleukin-2 (IL-2) can boost the immune system of these patients.
Doctors are not sure which anti-HIV drug combination is best to use in patients who have early HIV infection and have never received anti-HIV treatment. PIs are anti-HIV drugs that decrease viral load (level of HIV in the blood). However, PIs can cause serious side effects in some patients. Doctors would like to know if a drug combination that does not contain a PI is just as good as one that contains PIs.
- Detailed Description
Studies have suggested that an antiretroviral drug regimen of the non-nucleoside agent efavirenz (EFV) in combination with two nucleoside analogues is effective at achieving maximal viral suppression. This provides an alternative treatment to that of the more toxic PI-containing regimen. This trial examines whether a nonPI regimen with EFV is more beneficial than a PI-containing regimen when each is used in combination with the same two nucleoside analogues. A second part of the study looks at whether the addition of IL-2 may offer immunologic benefits as a co-administered drug.
Patients are randomized to initiate antiretroviral therapy of a PI-based (stavudine/didanosine/ritonavir \[RTV\]/indinavir \[IDV\]) or nonPI-based (stavudine/didanosine/EFV) regimen. Within these treatment arms, they are stratified according to a positive or negative p24 antigen result. At Week 16, patients not achieving maximal viral suppression (lower than 50 copies/ml) have the option to add abacavir (ABC) or other drugs as intensification therapy. Those achieving virologic suppression (less than 50 copies/ml) are randomized either to receive IL-2 or not. At study entry, and after 12 months, tissue samples of CSF, lymph node, and genital secretions are obtained, with permission. Patients have physical exams, women of child-bearing potential have pregnancy tests, and blood samples are drawn at clinic visits 12-16 times a year over 3 years so that virologic and immunologic evaluations may be performed. Compensation for time and transportation is given.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Indinavir sulfate Patients will receive combination antiretroviral therapy with a protease inhibitor A Ritonavir Patients will receive combination antiretroviral therapy with a protease inhibitor A Abacavir sulfate Patients will receive combination antiretroviral therapy with a protease inhibitor B Abacavir sulfate Patients will receive combination antiretroviral therapy without a protease inhibitor A Aldesleukin Patients will receive combination antiretroviral therapy with a protease inhibitor A Didanosine Patients will receive combination antiretroviral therapy with a protease inhibitor B Efavirenz Patients will receive combination antiretroviral therapy without a protease inhibitor B Stavudine Patients will receive combination antiretroviral therapy without a protease inhibitor B Didanosine Patients will receive combination antiretroviral therapy without a protease inhibitor B Aldesleukin Patients will receive combination antiretroviral therapy without a protease inhibitor
- Primary Outcome Measures
Name Time Method Virologic: A. Plasma viral load B. Tissue viral load (CNS, lymphoid tissues, genital tract) C. HIV DNA (proviral) levels in circulating mononuclear cells D. Phenotypic and genotypic antiretroviral drug resistance Throughout study Immunologic: A. Evaluation of CD4, CD8, CD45RA, CD45RO phenotypes and defined activation markers B. Evaluation of the diversity and persistence of the T cell repertoire (CD4+, CD8+) in the circulation and lymphoid tissues Throughout study Immunologic: C. Functional CD4+ cellular assays (class II MHC tetramers) D. Thymic regeneration as studied by the exclusion circle assay E. Evolution of Western blot banding patterns F. Evolution of anti-HIV neutralizing antibody levels Throughout study Clinical: A. Minor opportunistic infections or AIDS-defining conditions B. Death C. Clinical or laboratory adverse events D. Evaluation of adherence to therapy E. Evaluation of lipodystrophy Throughout study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Centre Hospitalier de la Universite de Montreal (CHUM)
🇨🇦Montreal, Quebec, Canada
Centre de traitment d'immunodeficience
🇨🇦Montreal, Quebec, Canada
Viridae Clinical Sciences / University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Institut Thoracique de Montreal
🇨🇦Montreal, Quebec, Canada