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Pilot study of saquinavir and lopinavir/ritonavir twice daily in protease inhibitor-naive HIV-positive patients.
HIV Clin Trials. 2005 Mar-Apr; 6(2):107-17.HC

Abstract

PURPOSE

Protease inhibitor (PI)-naive patients may have limited reverse transcriptase inhibitor (RTI) options due to resistance and/or toxicity. Effective, well-tolerated nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens are therefore needed.

METHOD

This prospective study evaluated the efficacy and safety of saquinavir/lopinavir/ritonavir (1000/400/100 mg bid) in PI-naive patients over 48 weeks. The regimen could be intensified with NRTIs if patients did not achieve virologic suppression by 12 weeks. The primary study endpoint was virologic suppression at 48 weeks. Additional study objectives included assessment of safety, CD4 cell counts, blood lipids, PI trough levels, and anthropometrics.

RESULTS

Of the 20 PI-naive study participants, 16 completed 48 weeks of study treatment, with no discontinuations attributed to virologic failure. Fourteen of 16 patients achieved virologic suppression with only the PIs; 2 patients required tenofovir intensification to achieve complete suppression. Median CD4 counts increased significantly over 48 weeks. Adverse events were generally mild and manageable. Extreme lipid elevations were uncommon, although moderate lipid elevations occurred in the majority of patients. Most patients reported some degree of central fat accumulation.

CONCLUSION

Our study demonstrates that saquinavir/lopinavir/ritonavir 1000/400/100 mg bid with tenofovir intensification is a potent nucleoside-sparing regimen for PI-naive patients, associated with durable HIV suppression and improved CD4 cell counts. Fat accumulation and metabolic changes observed in this study warrant confirmation from ongoing trials.

Authors+Show Affiliations

CRI of New England, Boston and Springfield, MA, USA. jhellinger@tufts-nemc.orgNo 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
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15983895

Citation

Hellinger, James, et al. "Pilot Study of Saquinavir and Lopinavir/ritonavir Twice Daily in Protease Inhibitor-naive HIV-positive Patients." HIV Clinical Trials, vol. 6, no. 2, 2005, pp. 107-17.
Hellinger J, Cohen C, Morris A, et al. Pilot study of saquinavir and lopinavir/ritonavir twice daily in protease inhibitor-naive HIV-positive patients. HIV Clin Trials. 2005;6(2):107-17.
Hellinger, J., Cohen, C., Morris, A., Sheble-Hall, S., Gordon, D., Foy, C., Jackson-Pope, L., Shevitz, A., & van Schaic, E. (2005). Pilot study of saquinavir and lopinavir/ritonavir twice daily in protease inhibitor-naive HIV-positive patients. HIV Clinical Trials, 6(2), 107-17.
Hellinger J, et al. Pilot Study of Saquinavir and Lopinavir/ritonavir Twice Daily in Protease Inhibitor-naive HIV-positive Patients. HIV Clin Trials. 2005 Mar-Apr;6(2):107-17. PubMed PMID: 15983895.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pilot study of saquinavir and lopinavir/ritonavir twice daily in protease inhibitor-naive HIV-positive patients. AU - Hellinger,James, AU - Cohen,Calvin, AU - Morris,Anne, AU - Sheble-Hall,Sandy, AU - Gordon,Danielle, AU - Foy,Clarissa, AU - Jackson-Pope,Lenore, AU - Shevitz,Abby, AU - van Schaic,Erno, PY - 2005/6/29/pubmed PY - 2005/10/4/medline PY - 2005/6/29/entrez SP - 107 EP - 17 JF - HIV clinical trials JO - HIV Clin Trials VL - 6 IS - 2 N2 - PURPOSE: Protease inhibitor (PI)-naive patients may have limited reverse transcriptase inhibitor (RTI) options due to resistance and/or toxicity. Effective, well-tolerated nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens are therefore needed. METHOD: This prospective study evaluated the efficacy and safety of saquinavir/lopinavir/ritonavir (1000/400/100 mg bid) in PI-naive patients over 48 weeks. The regimen could be intensified with NRTIs if patients did not achieve virologic suppression by 12 weeks. The primary study endpoint was virologic suppression at 48 weeks. Additional study objectives included assessment of safety, CD4 cell counts, blood lipids, PI trough levels, and anthropometrics. RESULTS: Of the 20 PI-naive study participants, 16 completed 48 weeks of study treatment, with no discontinuations attributed to virologic failure. Fourteen of 16 patients achieved virologic suppression with only the PIs; 2 patients required tenofovir intensification to achieve complete suppression. Median CD4 counts increased significantly over 48 weeks. Adverse events were generally mild and manageable. Extreme lipid elevations were uncommon, although moderate lipid elevations occurred in the majority of patients. Most patients reported some degree of central fat accumulation. CONCLUSION: Our study demonstrates that saquinavir/lopinavir/ritonavir 1000/400/100 mg bid with tenofovir intensification is a potent nucleoside-sparing regimen for PI-naive patients, associated with durable HIV suppression and improved CD4 cell counts. Fat accumulation and metabolic changes observed in this study warrant confirmation from ongoing trials. SN - 1528-4336 UR - https://www.unboundmedicine.com/medline/citation/15983895/Pilot_study_of_saquinavir_and_lopinavir/ritonavir_twice_daily_in_protease_inhibitor_naive_HIV_positive_patients_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=15983895.ui DB - PRIME DP - Unbound Medicine ER -