A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Ritonavir (Drug); Abacavir sulfate (Drug); Efavirenz (Drug); Stavudine (Drug); Didanosine (Drug); Aldesleukin (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Rafick-Pierre Sekaly, Principal Investigator
Brian Conway, Principal Investigator
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.
Clinical Details
Official title: Randomized, Controlled, Open Label, Multi-Center Phase III Trial Comparing the Safety and Antiviral Activity of a Protease-Containing Regimen (d4T/ddI/IDV/RTV) Versus a Protease-Sparing Regimen (d4T/ddI/EFV) and the Ability of Interleukin-2 to Purge HIV From Latent Stores in Patients With Acute/Early HIV Infection
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Primary outcome: 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 resistanceImmunologic:
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 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 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
- Have been infected recently with HIV. This will be determined by certain lab tests.
- Are 18 years of age or older.
- Are able to swallow a large number of pills.
- Are willing to use barrier methods of birth control (such as condoms) during the
study.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Abuse drugs or alcohol.
- Have any condition that, in the opinion of the investigator, could impair their
ability to participate in the study.
- Are breast-feeding or pregnant.
- Have received any prior anti-HIV drugs. (However, use of anti-HIV drugs to try to
prevent infection more than 6 months prior to study entry is allowed.)
Locations and Contacts
Viridae Clinical Sciences / University of British Columbia, Vancouver, British Columbia, Canada
Centre Hospitalier de la Universite de Montreal (CHUM), Montreal, Quebec, Canada
Institut Thoracique de Montreal, Montreal, Quebec, Canada
Centre de traitment d'immunodeficience, Montreal, Quebec, Canada
Additional Information
Click here for more information about Didanosine Click here for more information about Aldesleukin Click here for more information about Stavudine Click here for more information about Indinavir sulfate Click here for more information about Ritonavir Click here for more information about Abacavir sulfate Click here for more information about Efavirenz Haga clic aquí para ver información sobre este ensayo clínico en español.
Starting date: September 2009
Last updated: April 23, 2009
|
