Virological and immunological responses to once-daily dosing of didanosine in combination with stavudine

Jane E. Mobley, Richard B Pollard, Shannon Schrader, Myra H. Adler, Thomas Kelleher, Colin McLaren

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Objective: To compare the antiviral activity of once-daily didanosine (ddl) and twice-daily ddl in combination with stavudine (d4T). Design: Randomized, double-blind, multicenter study. Setting: Twenty-one sites in the United States. Patients: Eighty-seven antiretroviral-naive, HIV-1-infected adults with baseline plasma HIV RNA counts of ≥ 10,000 copies/ml and CD4 cell counts of ≥ 100 cells/mm3 started study therapy. Interventions: Patients received once-daily ddl or twice-daily ddl, each combined with twice-daily d4T. Main outcome measures: Plasma HIV-1 RNA levels, CD4 cell counts, and adverse events were regularly monitored. The primary efficacy analysis used was the time-averaged difference (TAD) between treatment regimens in change from baseline plasma HIV-1 RNA levels over the first 12 weeks of therapy. Results: At week 12, median log10 HIV-1 RNA changes were -1.83 log10 copies/ml in the once-daily ddl/d4T group and -1.80 log10 copies/ml in the twice-daily ddl/d4T group, and 18 out of 44 patients (41%) and 17 out of 43 patients (40%), respectively, had HIV-1 RNA levels below 400 copies/ml. Similar results were seen at week 24. The TAD between the two treatment groups (once-daily ddl/d4T minus twice-daily ddl/d4T) in change from baseline plasma HIV RNA levels over the first 12 weeks was 0.14 log10 copies/ml (95% CI: -0.11, 0.40). At week 12, subjects averaged an increase in CD4 cell count of over 140 cells/mm3. The TAD between the two treatment groups in change from baseline CD4 cell counts over the first 12 weeks was 2 cells/mm3 (95% CI: -40, 45). Conclusion: Once-daily ddl plus d4T and twice-daily ddl plus d4T were similarly effective in reducing plasma HIV-1 RNA levels and increasing CD4 cell counts over 12-24 weeks of therapy.

Original languageEnglish (US)
JournalAIDS
Volume13
Issue number11
DOIs
StatePublished - 1999
Externally publishedYes

Fingerprint

Stavudine
Didanosine
HIV-1
CD4 Lymphocyte Count
RNA
Therapeutics
HIV
Double-Blind Method
Multicenter Studies
Antiviral Agents
Outcome Assessment (Health Care)

Keywords

  • Antiretroviral therapy
  • Didanosine
  • HIV-1
  • Reverse transcriptase inhibitor
  • Stavudine

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Virological and immunological responses to once-daily dosing of didanosine in combination with stavudine. / Mobley, Jane E.; Pollard, Richard B; Schrader, Shannon; Adler, Myra H.; Kelleher, Thomas; McLaren, Colin.

In: AIDS, Vol. 13, No. 11, 1999.

Research output: Contribution to journalArticle

Mobley, Jane E. ; Pollard, Richard B ; Schrader, Shannon ; Adler, Myra H. ; Kelleher, Thomas ; McLaren, Colin. / Virological and immunological responses to once-daily dosing of didanosine in combination with stavudine. In: AIDS. 1999 ; Vol. 13, No. 11.
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abstract = "Objective: To compare the antiviral activity of once-daily didanosine (ddl) and twice-daily ddl in combination with stavudine (d4T). Design: Randomized, double-blind, multicenter study. Setting: Twenty-one sites in the United States. Patients: Eighty-seven antiretroviral-naive, HIV-1-infected adults with baseline plasma HIV RNA counts of ≥ 10,000 copies/ml and CD4 cell counts of ≥ 100 cells/mm3 started study therapy. Interventions: Patients received once-daily ddl or twice-daily ddl, each combined with twice-daily d4T. Main outcome measures: Plasma HIV-1 RNA levels, CD4 cell counts, and adverse events were regularly monitored. The primary efficacy analysis used was the time-averaged difference (TAD) between treatment regimens in change from baseline plasma HIV-1 RNA levels over the first 12 weeks of therapy. Results: At week 12, median log10 HIV-1 RNA changes were -1.83 log10 copies/ml in the once-daily ddl/d4T group and -1.80 log10 copies/ml in the twice-daily ddl/d4T group, and 18 out of 44 patients (41{\%}) and 17 out of 43 patients (40{\%}), respectively, had HIV-1 RNA levels below 400 copies/ml. Similar results were seen at week 24. The TAD between the two treatment groups (once-daily ddl/d4T minus twice-daily ddl/d4T) in change from baseline plasma HIV RNA levels over the first 12 weeks was 0.14 log10 copies/ml (95{\%} CI: -0.11, 0.40). At week 12, subjects averaged an increase in CD4 cell count of over 140 cells/mm3. The TAD between the two treatment groups in change from baseline CD4 cell counts over the first 12 weeks was 2 cells/mm3 (95{\%} CI: -40, 45). Conclusion: Once-daily ddl plus d4T and twice-daily ddl plus d4T were similarly effective in reducing plasma HIV-1 RNA levels and increasing CD4 cell counts over 12-24 weeks of therapy.",
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T1 - Virological and immunological responses to once-daily dosing of didanosine in combination with stavudine

AU - Mobley, Jane E.

AU - Pollard, Richard B

AU - Schrader, Shannon

AU - Adler, Myra H.

AU - Kelleher, Thomas

AU - McLaren, Colin

PY - 1999

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N2 - Objective: To compare the antiviral activity of once-daily didanosine (ddl) and twice-daily ddl in combination with stavudine (d4T). Design: Randomized, double-blind, multicenter study. Setting: Twenty-one sites in the United States. Patients: Eighty-seven antiretroviral-naive, HIV-1-infected adults with baseline plasma HIV RNA counts of ≥ 10,000 copies/ml and CD4 cell counts of ≥ 100 cells/mm3 started study therapy. Interventions: Patients received once-daily ddl or twice-daily ddl, each combined with twice-daily d4T. Main outcome measures: Plasma HIV-1 RNA levels, CD4 cell counts, and adverse events were regularly monitored. The primary efficacy analysis used was the time-averaged difference (TAD) between treatment regimens in change from baseline plasma HIV-1 RNA levels over the first 12 weeks of therapy. Results: At week 12, median log10 HIV-1 RNA changes were -1.83 log10 copies/ml in the once-daily ddl/d4T group and -1.80 log10 copies/ml in the twice-daily ddl/d4T group, and 18 out of 44 patients (41%) and 17 out of 43 patients (40%), respectively, had HIV-1 RNA levels below 400 copies/ml. Similar results were seen at week 24. The TAD between the two treatment groups (once-daily ddl/d4T minus twice-daily ddl/d4T) in change from baseline plasma HIV RNA levels over the first 12 weeks was 0.14 log10 copies/ml (95% CI: -0.11, 0.40). At week 12, subjects averaged an increase in CD4 cell count of over 140 cells/mm3. The TAD between the two treatment groups in change from baseline CD4 cell counts over the first 12 weeks was 2 cells/mm3 (95% CI: -40, 45). Conclusion: Once-daily ddl plus d4T and twice-daily ddl plus d4T were similarly effective in reducing plasma HIV-1 RNA levels and increasing CD4 cell counts over 12-24 weeks of therapy.

AB - Objective: To compare the antiviral activity of once-daily didanosine (ddl) and twice-daily ddl in combination with stavudine (d4T). Design: Randomized, double-blind, multicenter study. Setting: Twenty-one sites in the United States. Patients: Eighty-seven antiretroviral-naive, HIV-1-infected adults with baseline plasma HIV RNA counts of ≥ 10,000 copies/ml and CD4 cell counts of ≥ 100 cells/mm3 started study therapy. Interventions: Patients received once-daily ddl or twice-daily ddl, each combined with twice-daily d4T. Main outcome measures: Plasma HIV-1 RNA levels, CD4 cell counts, and adverse events were regularly monitored. The primary efficacy analysis used was the time-averaged difference (TAD) between treatment regimens in change from baseline plasma HIV-1 RNA levels over the first 12 weeks of therapy. Results: At week 12, median log10 HIV-1 RNA changes were -1.83 log10 copies/ml in the once-daily ddl/d4T group and -1.80 log10 copies/ml in the twice-daily ddl/d4T group, and 18 out of 44 patients (41%) and 17 out of 43 patients (40%), respectively, had HIV-1 RNA levels below 400 copies/ml. Similar results were seen at week 24. The TAD between the two treatment groups (once-daily ddl/d4T minus twice-daily ddl/d4T) in change from baseline plasma HIV RNA levels over the first 12 weeks was 0.14 log10 copies/ml (95% CI: -0.11, 0.40). At week 12, subjects averaged an increase in CD4 cell count of over 140 cells/mm3. The TAD between the two treatment groups in change from baseline CD4 cell counts over the first 12 weeks was 2 cells/mm3 (95% CI: -40, 45). Conclusion: Once-daily ddl plus d4T and twice-daily ddl plus d4T were similarly effective in reducing plasma HIV-1 RNA levels and increasing CD4 cell counts over 12-24 weeks of therapy.

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