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Protease Data at a Glance

From Gay Men's Health Crisis

Ritonavir

Baselines: median CD4 cell count was 18 in the ritonavir arm and 22 in the placebo group. The median HIV plasma viral load was over 250,000 copies per ml. Median follow-up of 6.1 months (range: 0.2-7 months). (abstract LB6a)
Clinical Endpoint Study
Ritonavir
(n = 543†)		 Placebo
(n = 547†)
AIDS or Death 85 181
Death 26 46
Discontinuation
due to side effects		 91 42
32 patients enrolled, eleven dropped out because of side effects. (abstract 285)
Open-Label Ritonavir/AZT/ddC Study
Median Baseline Month l Month 2 Month 3 Month 4 Month 5 Month 6
CD4 156 292 268 274 277 309 303
Plasma Viral Load 69780 1045 343 636 229 351 892
Mean log change in viral load -1.96 -2.33 -2.44 -2.52 -2.92 -2.46


Indinavir

Median baseline CD4 count = 250
Median baseline viral load = 126,000 (5.1 log)
Indinavir Monotherapy Study in 70 Patients
week 8 week 16 week 24
Measurement CD4 Viral load CD4 Viral load CD4 Viral load
800 mg 3x daily +60 -1.9 log +120 -2.3 log +80 -2.3 log
1000 mg 3x daily +60 -2.3 log +105 -2.4 log +105 -2.6 log
800 mg 4x daily +110 -1.8 log +100 -1.9 log +160 N.A.
Indinavir/AZT/3TC study: the study enrolled 97 people with at least 6 months of prior AZT therapy, Median baseline viral load was 40,000 copies (4.6 log) per ml, and the median CD4 cell count was 142. Figures derived from abstract LB7.
Indinavir/AZT/3TC Study
Regimen Maximum viral load reduction Viral load reduction Week 24 Percent below assay detection* week 24 CD4 Week 24 (n†)
Indinavir
+AZT/3TC		 more than 2 log more than 2 log 86% 146 (7)
Indinavir 1.6 log 1.3 log 44% 77 (9)
AZT/3TC 1.4 log 0.6 log 0% 22 (8)
24-week study of indinavir plus AZT/ddI versus indinavir or AZT/ddI (abstract 200). 78 antiretroviral naive patients. Median CD4 counts about 150 and median viral load approximately 5 log (100,000).
Indinavir/AZT/ddI Study
Regimen Maximum viral load reduction Viral load reduction week 24 Percent below assay detection* week 24 Maximum increase CD4 CD4 Week 24
Indinavir
+AZT/ddI		 2.9 log 2.9 log 40% +110 +90
Indinavir 1.9 log 1 log 15% +100 +100
AZT/ddI 1.5 log 1 log 15% +70 +25


Nelfinavir

Ten patients per arm with average baseline viral loads ranging from 50,000-60,000 copies per ml.
Nelfinavir Dose-Ranging Study
Daily nelfinavir Dose Percent with more than 1 log reduction Percent with more than 1.5 log reduction Percent below assay detection*
1500 mg 60% 30% 20%
2250 mg 90% 90% 60%
3000 mg 90% 70% 50%
The median range of viral load per arm at baseline was 50,000-70,000.
Nelfinavir/d4T Study
Regimen Percent with more than 1.5 log reduction day 28 Percent below assay detection* Viral load reduction day 45 (n†)
nelfinavir/d4T arms combined 100% (n = 17†) 77% (n = 17†) 2.4-2.6 log (3 to 4 patients per arm)

* 500 viral copies per ml.
† n = number of subjects with data


  
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This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues.
 
 

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