Protease Data at a Glance

HIV/AIDS Basics & Prevention

Just Diagnosed

HIV Treatment

Living With HIV

AIDS Policy & Activism

HIV Around the World

Conference Coverage

Gay Men's Health Crisis

Protease Data at a Glance

Ritonavir

	Clinical Endpoint Study
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)
		Ritonavir (n = 543^†)	Placebo (n = 547^†)
	AIDS or Death	85	181
	Death	26	46
	Discontinuation due to side effects	91	42

	Open-Label Ritonavir/AZT/ddC Study
32 patients enrolled, eleven dropped out because of side effects. (abstract 285)
	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

	Indinavir Monotherapy Study in 70 Patients
Median baseline CD4 count = 250 Median baseline viral load = 126,000 (5.1 log)
		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
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.
	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)

	Indinavir/AZT/ddI Study
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).
	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

	Nelfinavir Dose-Ranging Study
Ten patients per arm with average baseline viral loads ranging from 50,000-60,000 copies per ml.
	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%

	Nelfinavir/d4T Study
The median range of viral load per arm at baseline was 50,000-70,000.
	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

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

The Body is a service of Body Health Resources Corporation, 250 West 57th Street, New York, NY 10107. The Body and its logos are trademarks of Body Health Resources Corporation, which owns the copyright of The Body's homepage, topic pages, page designs and HTML code. General Disclaimer: The Body is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through The Body should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.

Ritonavir

Indinavir

Nelfinavir

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

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