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Randomized, Open-Label 2x2 Factorial Study to Compare the Safety and Efficacy of Different Combination Antiretroviral Therapy Regimens in Treatment Naive Patients With Advanced HIV Disease and/or CD4+ Cell Counts Less Than 200 Cells/MicroL

Trial Profile

Randomized, Open-Label 2x2 Factorial Study to Compare the Safety and Efficacy of Different Combination Antiretroviral Therapy Regimens in Treatment Naive Patients With Advanced HIV Disease and/or CD4+ Cell Counts Less Than 200 Cells/MicroL

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 03 Nov 2021

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At a glance

  • Drugs Didanosine (Primary) ; Efavirenz (Primary) ; Lopinavir/ritonavir (Primary) ; Stavudine (Primary) ; Zidovudine (Primary) ; Antiretrovirals; Lamivudine; Lamivudine/stavudine
  • Indications HIV infections
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms PHIDISA II
  • Most Recent Events

    • 18 Jun 2011 Results of a subgroup analysis reporting the prevalence of NNRTI drug resistance mutations in patients who achieved viral load <400 copies/mL at 6 months but subsequently had 2 consecutive measures of >1000 copies/mL have been reported in JAIDS.
    • 13 Oct 2010 Results were published in the Journal of Infectious Diseases.
    • 19 Feb 2010 Results of a sub-study of genotypic resistance at viral rebound have been reported at the 17th Conference on Retroviruses and Opportunistic Infections (CROI 2010).
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