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- Klinische proef NCT00006154
A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection
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
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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British Columbia
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Vancouver, British Columbia, Canada
- Viridae Clinical Sciences / University of British Columbia
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Quebec
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Montreal, Quebec, Canada
- Centre Hospitalier de la Universite de Montreal (CHUM)
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Montreal, Quebec, Canada
- Centre de traitment d'immunodeficience
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Montreal, Quebec, Canada
- Institut Thoracique de Montreal
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: A
Patients will receive combination antiretroviral therapy with a protease inhibitor
|
400 mg tablets equaling 1600 mg daily
Andere namen:
100 mg liquid capsules equaling 400 mg daily
Andere namen:
300 mg capsules equaling 600 mg daily.
Administration based on individual results after 16 weeks.
Andere namen:
250-400 mg E.coated tablets equaling 250 or 400 mg daily
Andere namen:
Subcutaneous injection equaling 15 x 10^6 IU daily dose.
Administration based on individual results after 16 weeks and randomization.
Andere namen:
|
Actieve vergelijker: B
Patients will receive combination antiretroviral therapy without a protease inhibitor
|
300 mg capsules equaling 600 mg daily.
Administration based on individual results after 16 weeks.
Andere namen:
250-400 mg E.coated tablets equaling 250 or 400 mg daily
Andere namen:
Subcutaneous injection equaling 15 x 10^6 IU daily dose.
Administration based on individual results after 16 weeks and randomization.
Andere namen:
200 mg capsules equaling 600 mg daily
Andere namen:
30-40 mg capsules equaling 60 or 80 mg daily
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
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
Tijdsspanne: Throughout study
|
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
Tijdsspanne: Throughout study
|
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
Tijdsspanne: Throughout study
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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
Tijdsspanne: Throughout study
|
Throughout study
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Rafick-Pierre Sekaly
- Hoofdonderzoeker: Brian Conway
Studie record data
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- RNA-virusinfecties
- Virusziekten
- Door bloed overgedragen infecties
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- Ziekte attributen
- Langzame virusziekten
- HIV-infecties
- Infecties
- Overdraagbare ziekten
- Verworven Immunodeficiëntie Syndroom
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Reverse Transcriptase-remmers
- Nucleïnezuursyntheseremmers
- Enzymremmers
- Anti-hiv-middelen
- Antiretrovirale middelen
- Antimetabolieten
- Antineoplastische middelen
- Proteaseremmers
- Cytochroom P-450 CYP3A-remmers
- Cytochroom P-450 enzymremmers
- Cytochroom P-450 enzyminductoren
- Cytochroom P-450 CYP3A-inductoren
- HIV-proteaseremmers
- Virale proteaseremmers
- Cytochroom P-450 CYP2B6-inductoren
- Cytochroom P-450 CYP2C9-remmers
- Cytochroom P-450 CYP2C19-remmers
- Aldesleukine
- Ritonavir
- Stavudine
- Indinavir
- Didanosine
- Efavirenz
- Abacavir
Andere studie-ID-nummers
- AI-07-001
- CTN #124
- 11530 (Register-ID: DAIDS-ES)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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