AEGiS-07CROI: A prospective open label pilot trial of a maintenance nevirapine (NVP)-containing regimen in patients with undetectable viral loads (VL) on protease inhibitor (PI) regimens for at least 6 months.

7th Conference on Retroviruses and Opportunistic Infections

San Francisco, CA - January 30 -February 4, 2000

A PROSPECTIVE OPEN LABEL PILOT TRIAL OF A MAINTENANCE NEVIRAPINE (NVP)-CONTAINING REGIMEN IN PATIENTS WITH UNDETECTABLE VIRAL LOADS (VL) ON PROTEASE INHIBITOR (PI) REGIMENS FOR AT LEAST 6 MONTHS.

Conf Retroviruses Opportunistic Infect 2000 Jan 30-Feb 2; 7:83 (abstract no. 45)

P. Tebas, K. Yarasheski, W. G. Powderly, E. Kane, D. Marin, J. Simpson, S. Claxton, M. Klebert, And K. Henry
Washington Univ., St. Louis, MO; and Regions Hosp., St. Paul, MN

BACKGROUND: Current potent antiretroviral regimens are complex and have significant metabolic toxicities. A possible strategy for simplification is the substitution of the PI by an NNRTI

METHODS: 40 HIV infected patients on their first PI containing regimen with undetectable VL for at least 6 months, switched the PI for NVP 200 mg bid. Nucleosides were maintained. All patients received prednisone 40 mg qd for 7 days. Patients intolerant to NVP were switched to efavirenz. Virologic failure was defined as a confirmed VL>200. All patients underwent intensive metabolic evaluations. A subset of patients also had insulin tolerance tests (ITT) and assesment of fat distribution with DEXA and MRI at 12 week intervals.

RESULTS: Patients were 90% males, median CD4 511. The median follow up is 24 weeks. 6 patients (15%) developed severe rash and switched to EFV, 1 patient dropped out of the study because of drug related hepatitis. There was 1 virologic failure in a patient whose VL became undetectable after switching back to a PI containing regimen. Fasting tryglycerides decreased by 31% (p=0.005), Cholesterol decreased 11% (p=NS). There was a decrease in insulin, proinsulin and C-peptide levels. 3/10 patients had evidence of insulin resistance at baseline (BL) using an insulin tolerance test. All 3 normalized their insulin response. Central to appendicular fat ratio measured with DEXA did not improve in the 6 patients with measurements at BL and week 24.

CONCLUSIONS: Switching to a NVP containing regimen maintains full virologic suppression in patients on their first successful PI containing regimen. Further follow up is required to assess the durability of this strategy beyond 24 weeks. Hypertryglyceridemia, hyperlipidemia and alterations of the glucose metabolism improved quickly after the switch to NVP suggesting a central role of PIs in the pathogenesis of these metabolic complications. No changes were observed in the fat redistribution syndrome at this early point.

Keywords: AEGIS, Nevirapine, Viral Load, Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents, HIV Protease Inhibitors, Oxazines, HIV Infections, HIV-1, HIV-1 Reverse Transcriptase, HIV, efavirenz, Human, Male, virology, AIDS

2000-01-30
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Copyright © 2000 - Foundation for Retrovirology and Human Health (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed from National Library of Medicine.