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ACTG 320: A Randomized Double-Blind, Phase III Study of Indinavir Sulfate (IDV) with Open-Label ZDV or Stavudine (d4T) and Lamivudine (3TC) in Subjects with HIV Infection with CD4 Cell Counts < = 200 Cells/mm3 and > = 3 Months of Prior Zidovudine Experience (on Diskette).

PB98502560

Publication Date	1998
Page Count	0
Abstract	ACTG 320 was a randomized, double-blind, placebo controlled trial that compared the three-drug regimen of indinavir, open-label zidovudine or stavudine, and lamivudine with the two-drug regimen of zidovudine and lamivudine in HIV-infected patients who had no more than 200 CD4 cells per cubic millimeter and at least three months of prior zidovudine therapy. The patients were recruited from 33 AIDS Clinical Trials Units and 7 National Hemophilia Foundation sites in the United States and Puerto Rico. A total of 1156 patients were assigned to one of the two drug regimens. The proportion of patients whose disease progressed to AIDS or death was lower with indinavir, zidovudine (or stavudine), and lamivudine (6%), than with zidovudine (or stavudine) and lamivudine alone (11%). Mortality in the two groups was 1.4% and 3.1%, respectively. The effects of treatment were similar in both CD4 cell strata. The responses of CD4 cells and plasma HIV-1 RNA paralleled the clinical results. This study shows that treatment with indinavir, zidovudine, and lamivudine as compared with zidovudine and lamivudine alone significantly slows the progression of HIV-1 disease in patients with 200 CD4 cells or fewer per cubic millimeter and prior exposure to zidovudine.
Keywords	Datafile AIDS Drug evaluation Human immunodeficiency syndrome Health care outcomes Preventive medicine Antiviral agents Drug therapy Clinical trials ZDV Stavudine Lamivudine Indinavir sulfate
Source Agency	National Institute of Allergy and Infectious Disease
Corporate Authors	National Inst. of Allergy and Infectious Diseases, Bethesda, MD. Div. of Acquired Immunodeficiency Syndrome.
Supplemental Notes	This product contains text only. Customers must provide their own search and retrieval software. SAS required.
Document Type	Computer Data File
Title Note	Data file.
NTIS Issue Number	199823

ACTG 320: A Randomized Double-Blind, Phase III Study of Indinavir Sulfate (IDV) with Open-Label ZDV or Stavudine (d4T) and Lamivudine (3TC) in Subjects with HIV Infection with CD4 Cell Counts < = 200 Cells/mm3 and > = 3 Months of Prior Zidovudine Experience (on Diskette).

ACTG 320: A Randomized Double-Blind, Phase III Study of Indinavir Sulfate (IDV) with Open-Label ZDV or Stavudine (d4T) and Lamivudine (3TC) in Subjects with HIV Infection with CD4 Cell Counts < = 200 Cells/mm3 and > = 3 Months of Prior Zidovudine Experience (on Diskette).
PB98502560

Publication Date	1998
Page Count	0
Abstract	ACTG 320 was a randomized, double-blind, placebo controlled trial that compared the three-drug regimen of indinavir, open-label zidovudine or stavudine, and lamivudine with the two-drug regimen of zidovudine and lamivudine in HIV-infected patients who had no more than 200 CD4 cells per cubic millimeter and at least three months of prior zidovudine therapy. The patients were recruited from 33 AIDS Clinical Trials Units and 7 National Hemophilia Foundation sites in the United States and Puerto Rico. A total of 1156 patients were assigned to one of the two drug regimens. The proportion of patients whose disease progressed to AIDS or death was lower with indinavir, zidovudine (or stavudine), and lamivudine (6%), than with zidovudine (or stavudine) and lamivudine alone (11%). Mortality in the two groups was 1.4% and 3.1%, respectively. The effects of treatment were similar in both CD4 cell strata. The responses of CD4 cells and plasma HIV-1 RNA paralleled the clinical results. This study shows that treatment with indinavir, zidovudine, and lamivudine as compared with zidovudine and lamivudine alone significantly slows the progression of HIV-1 disease in patients with 200 CD4 cells or fewer per cubic millimeter and prior exposure to zidovudine.
Keywords	Datafile AIDS Drug evaluation Human immunodeficiency syndrome Health care outcomes Preventive medicine Antiviral agents Drug therapy Clinical trials ZDV Stavudine Lamivudine Indinavir sulfate
Source Agency	National Institute of Allergy and Infectious Disease
Corporate Authors	National Inst. of Allergy and Infectious Diseases, Bethesda, MD. Div. of Acquired Immunodeficiency Syndrome.
Supplemental Notes	This product contains text only. Customers must provide their own search and retrieval software. SAS required.
Document Type	Computer Data File
Title Note	Data file.
NTIS Issue Number	199823