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Results of the ALBI trial: a randomized comparison of stavudine/didanosine, zidovudine/lamivudine and alternating treatment in antiretroviral-naive patients.
Antivir Ther. 1999; 4 Suppl 3:71-4.AT

Abstract

In the ALBI trial, 151 antiretroviral-naive patients with plasma human immunodeficiency virus type 1 (HIV-1) RNA levels of 10,000 to 100,000 copies/ml and CD4 cell counts > or = 200 cells/mm3 received 24 weeks of treatment with stavudine/didanosine (n=51), zidovudine/lamivudine (n=51) or stavudine/didanosine for 12 weeks followed by zidovudine/lamivudine (n=49). Baseline plasma HIV-1 RNA and CD4 cell counts were comparable in the treatment groups. The mean decrease in plasma HIV-1 RNA at 24 weeks in the stavudine/didanosine group (2.26 log10) was significantly greater than that in either the zidovudine/lamivudine group (1.26 log10) or the alternating treatment group (1.58 log10) (P<0.0001 for both). Proportions of patients with plasma HIV-1 RNA level <500 copies/ml (91% vs 42% and 60%) and <50 copies/ml (47% versus 4% and 9%) were significantly greater in the stavudine/didanosine group (P<0.001 for pairwise comparisons). Stavudine/didanosine was associated with a mean increase in CD4 cell count (124 cells/mm3) significantly greater than that in the zidovudine/lamivudine group (62 cells/mm3, P<0.01) and comparable to that in the alternating group (118 cells/mm3). All study regimens were well tolerated. These findings, indicating superiority of stavudine/didanosine over zidovudine/lamivudine in virological and immunological response over 24 weeks, suggest that the combination should be considered as a basis for highly active antiretroviral therapy.

Authors+Show Affiliations

Department of Infectious Diseases, Saint Louis Hospital, Paris, France. molina@chu-stlouis.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16021874

Citation

Molina, J M., et al. "Results of the ALBI Trial: a Randomized Comparison of Stavudine/didanosine, Zidovudine/lamivudine and Alternating Treatment in Antiretroviral-naive Patients." Antiviral Therapy, vol. 4 Suppl 3, 1999, pp. 71-4.
Molina JM, Chêuc G, Ferchal F, et al. Results of the ALBI trial: a randomized comparison of stavudine/didanosine, zidovudine/lamivudine and alternating treatment in antiretroviral-naive patients. Antivir Ther (Lond). 1999;4 Suppl 3:71-4.
Molina, J. M., Chêuc, G., Ferchal, F., Journot, V., Pellegrin, I., Sombardier, M. N., Rancinan, C., Cotte, L., Madelaine, I., Debord, T., & Decazes, J. M. (1999). Results of the ALBI trial: a randomized comparison of stavudine/didanosine, zidovudine/lamivudine and alternating treatment in antiretroviral-naive patients. Antiviral Therapy, 4 Suppl 3, 71-4.
Molina JM, et al. Results of the ALBI Trial: a Randomized Comparison of Stavudine/didanosine, Zidovudine/lamivudine and Alternating Treatment in Antiretroviral-naive Patients. Antivir Ther (Lond). 1999;4 Suppl 3:71-4. PubMed PMID: 16021874.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Results of the ALBI trial: a randomized comparison of stavudine/didanosine, zidovudine/lamivudine and alternating treatment in antiretroviral-naive patients. AU - Molina,J M, AU - Chêuc,G, AU - Ferchal,F, AU - Journot,V, AU - Pellegrin,I, AU - Sombardier,M N, AU - Rancinan,C, AU - Cotte,L, AU - Madelaine,I, AU - Debord,T, AU - Decazes,J M, AU - ,, PY - 2005/7/19/pubmed PY - 2005/8/13/medline PY - 2005/7/19/entrez SP - 71 EP - 4 JF - Antiviral therapy JO - Antivir. Ther. (Lond.) VL - 4 Suppl 3 N2 - In the ALBI trial, 151 antiretroviral-naive patients with plasma human immunodeficiency virus type 1 (HIV-1) RNA levels of 10,000 to 100,000 copies/ml and CD4 cell counts > or = 200 cells/mm3 received 24 weeks of treatment with stavudine/didanosine (n=51), zidovudine/lamivudine (n=51) or stavudine/didanosine for 12 weeks followed by zidovudine/lamivudine (n=49). Baseline plasma HIV-1 RNA and CD4 cell counts were comparable in the treatment groups. The mean decrease in plasma HIV-1 RNA at 24 weeks in the stavudine/didanosine group (2.26 log10) was significantly greater than that in either the zidovudine/lamivudine group (1.26 log10) or the alternating treatment group (1.58 log10) (P<0.0001 for both). Proportions of patients with plasma HIV-1 RNA level <500 copies/ml (91% vs 42% and 60%) and <50 copies/ml (47% versus 4% and 9%) were significantly greater in the stavudine/didanosine group (P<0.001 for pairwise comparisons). Stavudine/didanosine was associated with a mean increase in CD4 cell count (124 cells/mm3) significantly greater than that in the zidovudine/lamivudine group (62 cells/mm3, P<0.01) and comparable to that in the alternating group (118 cells/mm3). All study regimens were well tolerated. These findings, indicating superiority of stavudine/didanosine over zidovudine/lamivudine in virological and immunological response over 24 weeks, suggest that the combination should be considered as a basis for highly active antiretroviral therapy. SN - 1359-6535 UR - https://www.unboundmedicine.com/medline/citation/16021874/Results_of_the_ALBI_trial:_a_randomized_comparison_of_stavudine/didanosine_zidovudine/lamivudine_and_alternating_treatment_in_antiretroviral_naive_patients_ L2 - http://hivinsite.ucsf.edu/InSite?page=kb-03-03-05 DB - PRIME DP - Unbound Medicine ER -