Document Detail

Antiviral potency of HAART regimens and clinical success are not strictly coupled in real life conditions: evidence from the MASTER-1 study.
MedLine Citation:
PMID:  11673814     Owner:  NLM     Status:  MEDLINE    
PURPOSE: To compare in a real clinical setting the largely unknown midterm clinical effectiveness of two protease inhibitor (PI)-based highly active antiretroviral therapy (HAART) regimens with different potency and tolerability profiles in naïve patients. METHOD: This study was a multicenter, open-label, randomized trial in naïve patients with less than 400 CD4+ cell count/microL, regardless of viral load. Treatment arms were hard gel capsule saquinavir (HGC-SQV)-based HAART (Arm A), with an expected more favorable tolerability profile, and indinavir (IDV)-based HAART (Arm B), with more potent virologic activity. While viro-immunological surrogate markers and World Health Organization (WHO) grade III toxicity (secondary endpoints) were regularly monitored, primary endpoints of the study were clinical and defined as any AIDS-defining event, AIDS-related death, WHO grade IV toxicity, drop outs, and protocol violations. RESULTS: 262 consecutive patients were enrolled in the study from March 1, 1997 to December 31, 1997, in 24 different Italian clinical centers (132, Arm A; 130, Arm B). After 24 months of follow-up, patients who were enrolled in Arm B showed a significantly higher rate of virological success (75% had viremia below 500 copies/mL, CI = 12.9%, in the on-treatment analysis) and immunological gain (mean CD4+ cell count increase of 274 CD4+ cells/microL, SD = 234) when compared to patients enrolled in arm A (57%, CI = 15.5% and 223 CD4+ cells/microL, SD = 192; p =.0353 and.026, respectively). Despite the significant difference observed in surrogate markers, the number of total primary endpoints did not differ in the two groups (55 out of 132 in Arm A vs. 58 out of 130 person-years in Arm B; p =.86). CONCLUSION: Our results suggest that, after 24 months of follow-up in a real clinical setting, a PI-based HAART induces significant clinical benefits in naïve patients even in the absence of a complete suppression of viral replication. However, the long-term clinical impact of the possible accumulation of viral mutations in the presence of low-grade viral replication remains to be elucidated.
G Carosi; F Castelli; F Suter; F Maggiolo; A M Orani; A Pan; M Andreoni; G M Vigevani; R Maserati; F Mazzotta; C Tinelli;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  HIV clinical trials     Volume:  2     ISSN:  1528-4336     ISO Abbreviation:  HIV Clin Trials     Publication Date:    2001 Sep-Oct
Date Detail:
Created Date:  2001-10-23     Completed Date:  2001-12-07     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  100936377     Medline TA:  HIV Clin Trials     Country:  United States    
Other Details:
Languages:  eng     Pagination:  399-407     Citation Subset:  IM    
Institute of Infectious and Tropical Diseases, University of Brescia, Italy.
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MeSH Terms
Anti-HIV Agents / therapeutic use*
Antiretroviral Therapy, Highly Active
CD4 Lymphocyte Count
Cohort Studies
HIV Infections / drug therapy*,  immunology,  virology
HIV Protease Inhibitors / therapeutic use*
Indinavir / therapeutic use
Prospective Studies
Saquinavir / therapeutic use
Viral Load
Reg. No./Substance:
0/Anti-HIV Agents; 0/HIV Protease Inhibitors; 127779-20-8/Saquinavir; 150378-17-9/Indinavir

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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