- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00188851
Structured Treatment Interruption for HIV Patients With Virologic Failure
A Prospective Randomized Trial of Structured Treatment Interruption(STI) Followed by Initiation of a New Antiretroviral Regimen(ARV) Versus Immediate Switching to a New ARV in HIV-Infected Patients Experiencing Virologic Failure on HAART
The purpose of this study is to assess the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.
Hypothesis: A STI prior to starting a salvage regimen will result in an improved virologic response.
Studieoversikt
Detaljert beskrivelse
To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.
Hypothesis: By withdrawing ARV drug pressure, resistant HIV virus will revert to wild-type. In treatment-experienced HIV patients who experience virologic failure, a STI prior to starting a salvage regimen will result in an improved virologic response and more prolonged vral suppression compared to immediate switching to a new regime.
Interventions:
Immediate Switch to Salvage Therapy: Patients randomized to the control arm will be switched immediately to a salvage regimen using the information from the treatment history and genotype results.
Structured Treatment Interruption: Patients randomized to the STI arm will have their present regimen stopped for 12 weeks and will have a genotype repeated in the 12th week. A salvage regimen will be started at week 12 using the information from the treatment history and baseline genotype results.
Studietype
Registrering
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age > 18 years.
- On therapy with a triple ARV that includes a protease inhibitor and/or non-nucleoside reverse transcriptase inhibitor for the past 3 months with no changes in any agent of the combination in the past 14 days.
- Virologic failure while on the combination as defined by a plasma HIV RNA > 1000 copies/mL measured on 2 occasions at least 4 weeks apart.
- HIV RNA <500,000 copies/mL.
- CD4 cell count must be > 50/mm3
- Patients must not have a present history of opportunistic infections or acute illness requiring treatment within the preceding 30 days.
- The patient has at least two new ARV available based on history, and at least two of these new agents will be included in the new salvage regimen.
Exclusion Criteria:
- Active substance abuse which would interfere with the patient's ability to participate in this trial, or declared non-compliance.
- Pregnancy or breast feeding.
- Patients with any of the following abnormal laboratory test results at screening:· Hemoglobin<80 g/L, neutrophil count<750 cells/mL, Platelet<20,000 /mL· AST or ALT > 5X Upper Limit of Normal (ULN)· Creatinine > 250 umol/L
- End stage organ disease
- Patient with malignancy receiving systemic chemotherapy
- Patient has need for immune modulators (interleukin, interferon, GMCSF etc) or prednisone. This excludes a short course of inhaled or oral steroids for asthma exacerbation)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.
|
Sekundære resultatmål
Resultatmål |
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1. To prospectively determine differences in other virologic parameters through follow up between patients being switched to a salvage regimen with or without a STI.
|
2. To prospectively determine differences in change in CD4 count through follow up and at 24, 48 and 60 weeks following randomization between patients being switched to a salvage regimen with or without a STI.
|
3. To prospectively determine differences in the development or reactivation of opportunistic infections and survival between patients being switched to a salvage regimen with or without a STI at 60 weeks following randomization
|
4. To determine the proportion of virus of patients being treated with a STI that converts to wild-type and how that relates to the virologic response (% of patients with undetectable viral load sustained for 3 months).
|
5. To determine the impact of the STI on quality of life measures.
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6. To determine the genotypic resistance pattern of virus from patients who fail treatment after suppression to <50 copies/mL on the salvage regimen and to compare results in those who do and do not receive an STI.
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Mona Loutfy, MD, University Health Network, Toronto, On
- Studieleder: Joel Singer, MD, Canadian Trials Network, Vancouver, B.C.
- Studieleder: Janet Raboud, Dr., Univeristy Health Network, Toronto, On
- Studieleder: Stephen Shafran, MD, University of Alberta, Edmonton, Alberta
- Studieleder: Bill Cameron, MD, Ottawa Hospital, Ottawa, On
- Studieleder: Sylvie Trottier, MD, Clinique Medicale L'Actuel, Montreal, Quebec
- Studieleder: Richard Harrigan, MD, B.C. Centre of Excellence, Vancouver, B.C.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CIHR82716
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