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Protease Data at a Glance

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 Death85181
Death2646
Discontinuation
due to side effects
9142
32 patients enrolled, eleven dropped out because of side effects. (abstract 285)
Open-Label Ritonavir/AZT/ddC Study
MedianBaselineMonth lMonth 2Month 3Month 4Month 5Month 6
CD4156292268274277309303
Plasma Viral Load697801045343636229351892
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 8week 16week 24
MeasurementCD4Viral loadCD4Viral loadCD4Viral 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+160N.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
RegimenMaximum viral load reductionViral load reduction Week 24Percent below assay detection* week 24CD4 Week 24 (n)
Indinavir
+AZT/3TC
more than 2 logmore than 2 log86%146 (7)
Indinavir1.6 log1.3 log44%77 (9)
AZT/3TC1.4 log0.6 log0%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
RegimenMaximum viral load reductionViral load reduction week 24Percent below assay detection* week 24Maximum increase CD4CD4 Week 24
Indinavir
+AZT/ddI
2.9 log2.9 log40%+110+90
Indinavir1.9 log1 log15%+100+100
AZT/ddI1.5 log1 log15%+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 DosePercent with more than 1 log reductionPercent with more than 1.5 log reductionPercent below assay detection*
1500 mg60%30%20%
2250 mg90%90%60%
3000 mg90%70%50%
The median range of viral load per arm at baseline was 50,000-70,000.
Nelfinavir/d4T Study
RegimenPercent with more than 1.5 log reduction day 28Percent below assay detection*Viral load reduction day 45 (n)
nelfinavir/d4T arms combined100% (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. Visit GMHC's website to find out more about their activities, publications and services.
 

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