Efficacy and safety of abacavir plus lamivudine versus didanosine plus stavudine when combined with a protease inhibitor, a nonnucleoside reverse transcriptase inhibitor, or both in HIV-1 positive antiretroviral-naive persons

Rodger David MacArthur, L. Chen, G. Peng, R. M. Novak, M. van den Berg-Wolf, M. Kozal, L. Besch, T. Yurik, B. Schmetter, C. Henley, M. Dehlinger

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Purpose: The combination of abacavir + lamivudine (ABC+3TC) versus didanosine + stavudine (ddI+d4T), each combined with other classes of antiretrovirals (ARVs) in ARV-naive patients, was compared for the combined endpoint of time to plasma HIV RNA >50 copies/mL (at or after the 8-month visit) or death (primary endpoint) in a nested substudy of an ongoing multicenter randomized trial. Method: The substudy enrolled 182 patients; mean HIV RNA and CD4+ cell counts at baseline were 5.1 logl10 copies/mL and 212 cells/mm3, respectively. Results: After a median follow-up of 28 months, rates of primary endpoint were 57.2 and 67.8 per 100 person-years for the ABC+3TC and ddI+d4T groups (hazard ratio [HR] = 0.81, 95% confidence interval [CI] 0.58-1.14, p =.23). Conclusion: There was a trend for treatments containing ABC+3TC to be better than treatments containing ddI+d4T with respect to HIV RNA decreases, CD4+ cell count increases, and tolerability

Original languageEnglish (US)
Pages (from-to)361-370
Number of pages10
JournalHIV Clinical Trials
Volume5
Issue number6
DOIs
StatePublished - Nov 1 2004

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Stavudine
Didanosine
Reverse Transcriptase Inhibitors
Lamivudine
Protease Inhibitors
HIV-1
HIV
RNA
CD4 Lymphocyte Count
Safety
Multicenter Studies
Confidence Intervals
Therapeutics
lamivudine drug combination abacavir

Keywords

  • Antiretroviral agents
  • Controlled clinical trials
  • Highly active antiretroviral therapy
  • Reverse transcriptase inhibitors

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

Efficacy and safety of abacavir plus lamivudine versus didanosine plus stavudine when combined with a protease inhibitor, a nonnucleoside reverse transcriptase inhibitor, or both in HIV-1 positive antiretroviral-naive persons. / MacArthur, Rodger David; Chen, L.; Peng, G.; Novak, R. M.; van den Berg-Wolf, M.; Kozal, M.; Besch, L.; Yurik, T.; Schmetter, B.; Henley, C.; Dehlinger, M.

In: HIV Clinical Trials, Vol. 5, No. 6, 01.11.2004, p. 361-370.

Research output: Contribution to journalArticle

MacArthur, Rodger David ; Chen, L. ; Peng, G. ; Novak, R. M. ; van den Berg-Wolf, M. ; Kozal, M. ; Besch, L. ; Yurik, T. ; Schmetter, B. ; Henley, C. ; Dehlinger, M. / Efficacy and safety of abacavir plus lamivudine versus didanosine plus stavudine when combined with a protease inhibitor, a nonnucleoside reverse transcriptase inhibitor, or both in HIV-1 positive antiretroviral-naive persons. In: HIV Clinical Trials. 2004 ; Vol. 5, No. 6. pp. 361-370.
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AU - Chen, L.

AU - Peng, G.

AU - Novak, R. M.

AU - van den Berg-Wolf, M.

AU - Kozal, M.

AU - Besch, L.

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AU - Henley, C.

AU - Dehlinger, M.

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AB - Purpose: The combination of abacavir + lamivudine (ABC+3TC) versus didanosine + stavudine (ddI+d4T), each combined with other classes of antiretrovirals (ARVs) in ARV-naive patients, was compared for the combined endpoint of time to plasma HIV RNA >50 copies/mL (at or after the 8-month visit) or death (primary endpoint) in a nested substudy of an ongoing multicenter randomized trial. Method: The substudy enrolled 182 patients; mean HIV RNA and CD4+ cell counts at baseline were 5.1 logl10 copies/mL and 212 cells/mm3, respectively. Results: After a median follow-up of 28 months, rates of primary endpoint were 57.2 and 67.8 per 100 person-years for the ABC+3TC and ddI+d4T groups (hazard ratio [HR] = 0.81, 95% confidence interval [CI] 0.58-1.14, p =.23). Conclusion: There was a trend for treatments containing ABC+3TC to be better than treatments containing ddI+d4T with respect to HIV RNA decreases, CD4+ cell count increases, and tolerability

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