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3TC + ZDV in patients (pts) with CD4 under 50/mm3: a phase II study.

Michelet C, Ruffault A, Arvieux C, Guisth'au O, Favre C, Andrieux F, Colmon D, Cartier F; Conference on Retroviruses and Opportunistic Infections.

Program Abstr 3rd Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 3rd 1996 Wash D C. 1996 Jan 28-Feb 1; 3rd: 108.

University of Rennes, France.

3TC in combination with AZT is very attractive in pts with CD4 greater than 50/mm3: but only few data for pts under 50/mm3 were available. We evaluated the biological efficacy of 3TC 300 or 150 mg BID in combination with AZT 200 mg TID. Pts were enrolled if their CD4 was less than 50/mm3, Karnovsky greater than 70 and after failure or intolerance of AZT, ddI, ddC alone or in combination. Criteria of follow-up at JO, Month 1, 3, 6, were clinical examination, quantitative plasma viremia (VP) measured by culture as described by B. COOMBS (1988), cell viremia (VC), P24 antigenemia (P24 ag), CD4 cell count, phenotype SI/NSI. 17 pts were enrolled at CDC stage B3 8 pts, C3 9 pts. Pts were pretreated by antiretroviral agents since 32 months (862). The results are shown below: (table:see text). Month 1 : Mean decrease of VP was 1 log 10, AgP24 0,4 log and CD4 increased of 76%. VP Negativation or decrease of more than 1 log occurred in 8 pts. Month 3 : 6/12 pts (5 pts stopped AZT due to haematological intolerance) had a sustained improvement of CD4 (mean 27/mm -JO and 60/mm3 -M3) and a persistent decrease of VP in 4 pts. In 5 other pts VP increased rapidly. Mean AgP24 (12 pts) remained decreased (p value JO-M3 0.03). At Month 6 (on virologic evaluation), 15/17 pts were alive without new opportunistic infections, except one. In conclusion 3TC + ZDV had an important antiviral activity in pts with CD4 under 50/mm3 and could decrease the disease progression.

Publication Types:
  • Meeting Abstracts
Keywords:
  • Anti-Retroviral Agents
  • Antigens, CD4
  • Antiviral Agents
  • CD4 Lymphocyte Count
  • Centers for Disease Control and Prevention (U.S.)
  • Clinical Trials, Phase II as Topic
  • Didanosine
  • Disease Progression
  • Humans
  • Lamivudine
  • Viremia
  • Zalcitabine
  • Zidovudine
  • immunology
Other ID:
  • 96920299
UI: 102216350

From Meeting Abstracts




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