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)
|
 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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