Steinhart CR, George SA, Mann RD; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 4th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 4th 1997 Wash DC. 1997 Jan 22-26; 4th: 101 (abstract no. 199).
Mercy Hospital Special Immunology Services, Miami, FL.
Objective: to determine the safety and possible efficacy of combination protease inhibitor therapy with 2 nucleoside analogs in subjects intolerant to ritonavir. Methods: subjects with CD4 counts less than or equal to 100/mm3 not responding to combination therapy with 2 nucleoside analogs, and not able to tolerate ritonavir at the standard dose of 600 mg po bid were enrolled in an open-label trial. Subjects were continued on their current double-nucleoside therapy and given the combination of saquinavir, 800 mg po bid, and ritonavir, 400 mg po bid. Hematogical and biochemical measurements, plasma HIV RNA by RT-PCR, and CD4 lymphocyte counts were obtained at baseline and every 4 weeks during treatment. Results: To date, 8 subjects have been followed for 2-5 months. CD4 counts have increased in 7/8 subjects from a mean baseline value of 52 plus or minus 7 cells/mm3 to 152 plus or minus 25/mm3 at 3 months. Viral load has decreased from a mean baseline of 81,750 (4.65 log(10)) copies/ml to undetectable levels in 6/8 subjects. Mean reduction in viral load has been 1.71 log(10) copies/ml. All subjects have tolerated the combination well without any clinically significant changes in laboratory values. Conclusions: Combination antiretroviral therapy with 2 nucleosides and the protease inhibitors saquinavir and ritonavir in subjects with advanced HIV infection intolerant to the recommended dose of ritonavir leads to a reduction in plasma HIV RNA and an increase in CD4 count that that are sustained for greater than or equal to 3 months and is well-tolerated. Controlled trials of the 4-drug regimen are indicated to determine the long-term safety and efficacy of this combination in subjects with advanced HIV infection.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- CD4 Lymphocyte Count
- HIV Infections
- Humans
- Ritonavir
- Salvage Therapy
- Saquinavir
- Viral Load
Other ID:
UI: 102223513
From Meeting Abstracts