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An open randomized study comparing the influence of different therapeutic strategies (no treatment vs double therapy (ZDV/D4T + 3TC+)vs triple therapy (D4T + 3TC + indinavir) in the progression of chronic HIV-1 infected patients in very early stages (Spanish Early antiretroviral Therapy in HIV: Spanish EARTH-2 Study).

Garcia F, Romeu J, Grau I, Sambeat MA, Dalmau D, Knobel H, Gatell JM, Miro JM; International Conference on AIDS.

Int Conf AIDS. 1998; 12: 59 (abstract no. 12238).

Spanish EARTH Study Co-ordinating Committee, Spain.

BACKGROUND: The objective was to test whether maintaining a pre-established viral load (VL) reduction can delay progression in asymptomatic HIV-1 infected patients with CD4+T cell count > or = 500 x 10(6)/L and viral load > or = 5000 copies/ml. End points were evolution to < 500 CD4+ plus 2 symptoms of the category B, < 350 CD4+, category C or death. METHODS: Patients were randomly assigned to no treatment (N = 16), ZDV plus 3TC (N = 29), d4T plus 3TC (N = 30), d4t plus 3TC plus indinavir (N = 39). Recruitment of the control group was discontinued when the preliminary analysis of a similar study (Spanish EARTH-1) showed a worse outcome compared to all treatment arms. VL was measured at baseline at 1/2, 1, 2 and 4 months and every 4 months thereafter. Active treatment could be modified whenever necessary to maintain the targeted viral load reduction (< 1500 copies/ml in double therapy groups and < 200 copies/ml in triple therapy group). VL was also measured after 1/2 month and one month after every change in the therapeutic strategy. RESULTS: After 16 weeks of follow-up the virological response was: TABULAR DATA, SEE ABSTRACT VOLUME. within brackets are number of patients at risk No patients progressed to study end-points. Pre-established viral load reduction was maintained in all the patients: CONCLUSIONS: At 16 weeks of follow-up the proportion of patients with an undetectable level of viral load (< 200 copies/ml) was significantly higher in patients on triple therapy than in patients with double therapy in individuals with CD4+ T cell count > or = 500 x 10(6)/L and viral load > or = 5000 copies/ml. Longer follow-up, and VL measurements with an ultrasensible assay will be presented.

Publication Types:
  • Meeting Abstracts
Keywords:
  • AIDS Vaccines
  • Acquired Immunodeficiency Syndrome
  • Anti-HIV Agents
  • Antiretroviral Therapy, Highly Active
  • Biomedical Research
  • CD4 Lymphocyte Count
  • Disease Progression
  • Drug Therapy, Combination
  • HIV
  • HIV Infections
  • HIV Protease Inhibitors
  • HIV Seropositivity
  • HIV-1
  • Humans
  • Indinavir
  • Lamivudine
  • Stavudine
  • Viral Load
  • Zidovudine
  • drug therapy
  • therapy
Other ID:
  • 98387013
UI: 102227266

From Meeting Abstracts




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