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Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine

To compare the efficacy and safety of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine. Two multicenter, open-label, randomized 24-week studies. Adults HIV-1 infection, HIV-1 RNA greater than 10000 copies/ml, and no prior lamivudine or protease inhibit... Full description

Journal Title: AIDS (London) 2000, Vol.14 (13), p.1973-1978
Main Author: HAAS, David W
Other Authors: ARATHOON, Eduardo , BENETUCCI, Jorge , CAHN, Pedro , PAAR, David , WHITE, A. Clinton , COLLIER, Ann C , RAMIREZ-RONDA, Carlos H , HARVEY, Charlotte , CHUNG, Mi-Ok , MEHROTRA, Devan , CHODAKEWITZ, Jeffrey , THOMPSON, Melanie A , NGUYEN, Bach-Yen , PEDRO, Rogiero De , GALLANT, Joel E , UIP, David E , CURRIER, Judith , NORIEGA, L. Miguel , LEWI, David S , URIBE, Patricia
Format: Electronic Article Electronic Article
Language: English
Subjects:
Publisher: Hagerstown, MD: Lippincott Williams & Wilkins
ID: ISSN: 0269-9370
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recordid: cdi_proquest_miscellaneous_17703503
title: Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine
format: Article
creator:
  • HAAS, David W
  • ARATHOON, Eduardo
  • BENETUCCI, Jorge
  • CAHN, Pedro
  • PAAR, David
  • WHITE, A. Clinton
  • COLLIER, Ann C
  • RAMIREZ-RONDA, Carlos H
  • HARVEY, Charlotte
  • CHUNG, Mi-Ok
  • MEHROTRA, Devan
  • CHODAKEWITZ, Jeffrey
  • THOMPSON, Melanie A
  • NGUYEN, Bach-Yen
  • PEDRO, Rogiero De
  • GALLANT, Joel E
  • UIP, David E
  • CURRIER, Judith
  • NORIEGA, L. Miguel
  • LEWI, David S
  • URIBE, Patricia
subjects:
  • Adult
  • Anti-HIV Agents - adverse effects
  • Anti-HIV Agents - therapeutic use
  • Antibiotics. Antiinfectious agents. Antiparasitic agents
  • antiretroviral therapy
  • Antiretroviral Therapy, Highly Active
  • Antiviral agents
  • Biological and medical sciences
  • CD4 Lymphocyte Count
  • clinical trial
  • Drug Administration Schedule
  • HIV infection
  • HIV Infections - drug therapy
  • HIV Infections - virology
  • HIV protease inhibitors
  • HIV-1 - isolation & purification
  • HIV-1 - physiology
  • Human immunodeficiency virus 1
  • Humans
  • indinavir
  • Indinavir - administration & dosage
  • Indinavir - adverse effects
  • Indinavir - therapeutic use
  • lamivudine
  • Lamivudine - adverse effects
  • Lamivudine - therapeutic use
  • Medical sciences
  • Pharmacology. Drug treatments
  • Pilot Projects
  • Reverse Transcriptase Inhibitors - adverse effects
  • Reverse Transcriptase Inhibitors - therapeutic use
  • RNA, Viral - blood
  • Treatment Outcome
  • Viral Load
  • zidovudine
  • Zidovudine - adverse effects
  • Zidovudine - therapeutic use
ispartof: AIDS (London), 2000, Vol.14 (13), p.1973-1978
description: To compare the efficacy and safety of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine. Two multicenter, open-label, randomized 24-week studies. Adults HIV-1 infection, HIV-1 RNA greater than 10000 copies/ml, and no prior lamivudine or protease inhibitor therapy were eligible. In a pilot study (Study A), patients received indinavir at 800 mg every 8 h, 1000 mg every 12 h, or 1200 mg every 12 h. In a subsequent study (Study B), patients received indinavir at 800 mg every 8 h or 1200 mg every 12 h. All subjects received zidovudine (300 mg) and lamivudine (150 mg) every 12 h. An intent-to-treat analysis was used. In Study A, which enrolled 88 patients, neither HIV-1 RNA nor CD4 cell responses differed significantly between treatment groups at 24 weeks when corrected for multiple comparisons. Study B enrolled 433 patients, but was prematurely discontinued when interim analysis suggested greater efficacy of three-times-daily indinavir. Of the first 87 patients reaching week 24, HIV-1 RNA was less than 400 copies/ml in 91% receiving three-times-daily versus 64% receiving two-times-daily indinavir (P < 0.01). Three-times-daily indinavir appears more efficacious than two-times-daily dosing when administered with zidovudine and lamivudine. Two-times-daily indinavir dosing should only be considered in situations characterized by favorable pharmacokinetic drug-drug interactions.
language: eng
source:
identifier: ISSN: 0269-9370
fulltext: no_fulltext
issn:
  • 0269-9370
  • 1473-5571
url: Link


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titleComparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine
creatorHAAS, David W ; ARATHOON, Eduardo ; BENETUCCI, Jorge ; CAHN, Pedro ; PAAR, David ; WHITE, A. Clinton ; COLLIER, Ann C ; RAMIREZ-RONDA, Carlos H ; HARVEY, Charlotte ; CHUNG, Mi-Ok ; MEHROTRA, Devan ; CHODAKEWITZ, Jeffrey ; THOMPSON, Melanie A ; NGUYEN, Bach-Yen ; PEDRO, Rogiero De ; GALLANT, Joel E ; UIP, David E ; CURRIER, Judith ; NORIEGA, L. Miguel ; LEWI, David S ; URIBE, Patricia
creatorcontribHAAS, David W ; ARATHOON, Eduardo ; BENETUCCI, Jorge ; CAHN, Pedro ; PAAR, David ; WHITE, A. Clinton ; COLLIER, Ann C ; RAMIREZ-RONDA, Carlos H ; HARVEY, Charlotte ; CHUNG, Mi-Ok ; MEHROTRA, Devan ; CHODAKEWITZ, Jeffrey ; THOMPSON, Melanie A ; NGUYEN, Bach-Yen ; PEDRO, Rogiero De ; GALLANT, Joel E ; UIP, David E ; CURRIER, Judith ; NORIEGA, L. Miguel ; LEWI, David S ; URIBE, Patricia ; Protocol 054/069 Study Teams
descriptionTo compare the efficacy and safety of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine. Two multicenter, open-label, randomized 24-week studies. Adults HIV-1 infection, HIV-1 RNA greater than 10000 copies/ml, and no prior lamivudine or protease inhibitor therapy were eligible. In a pilot study (Study A), patients received indinavir at 800 mg every 8 h, 1000 mg every 12 h, or 1200 mg every 12 h. In a subsequent study (Study B), patients received indinavir at 800 mg every 8 h or 1200 mg every 12 h. All subjects received zidovudine (300 mg) and lamivudine (150 mg) every 12 h. An intent-to-treat analysis was used. In Study A, which enrolled 88 patients, neither HIV-1 RNA nor CD4 cell responses differed significantly between treatment groups at 24 weeks when corrected for multiple comparisons. Study B enrolled 433 patients, but was prematurely discontinued when interim analysis suggested greater efficacy of three-times-daily indinavir. Of the first 87 patients reaching week 24, HIV-1 RNA was less than 400 copies/ml in 91% receiving three-times-daily versus 64% receiving two-times-daily indinavir (P < 0.01). Three-times-daily indinavir appears more efficacious than two-times-daily dosing when administered with zidovudine and lamivudine. Two-times-daily indinavir dosing should only be considered in situations characterized by favorable pharmacokinetic drug-drug interactions.
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subjectAdult ; Anti-HIV Agents - adverse effects ; Anti-HIV Agents - therapeutic use ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; antiretroviral therapy ; Antiretroviral Therapy, Highly Active ; Antiviral agents ; Biological and medical sciences ; CD4 Lymphocyte Count ; clinical trial ; Drug Administration Schedule ; HIV infection ; HIV Infections - drug therapy ; HIV Infections - virology ; HIV protease inhibitors ; HIV-1 - isolation & purification ; HIV-1 - physiology ; Human immunodeficiency virus 1 ; Humans ; indinavir ; Indinavir - administration & dosage ; Indinavir - adverse effects ; Indinavir - therapeutic use ; lamivudine ; Lamivudine - adverse effects ; Lamivudine - therapeutic use ; Medical sciences ; Pharmacology. Drug treatments ; Pilot Projects ; Reverse Transcriptase Inhibitors - adverse effects ; Reverse Transcriptase Inhibitors - therapeutic use ; RNA, Viral - blood ; Treatment Outcome ; Viral Load ; zidovudine ; Zidovudine - adverse effects ; Zidovudine - therapeutic use
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0HAAS, David W
1ARATHOON, Eduardo
2BENETUCCI, Jorge
3CAHN, Pedro
4PAAR, David
5WHITE, A. Clinton
6COLLIER, Ann C
7RAMIREZ-RONDA, Carlos H
8HARVEY, Charlotte
9CHUNG, Mi-Ok
10MEHROTRA, Devan
11CHODAKEWITZ, Jeffrey
12THOMPSON, Melanie A
13NGUYEN, Bach-Yen
14PEDRO, Rogiero De
15GALLANT, Joel E
16UIP, David E
17CURRIER, Judith
18NORIEGA, L. Miguel
19LEWI, David S
20URIBE, Patricia
21Protocol 054/069 Study Teams
title
0Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine
1AIDS (London)
addtitleAIDS
descriptionTo compare the efficacy and safety of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine. Two multicenter, open-label, randomized 24-week studies. Adults HIV-1 infection, HIV-1 RNA greater than 10000 copies/ml, and no prior lamivudine or protease inhibitor therapy were eligible. In a pilot study (Study A), patients received indinavir at 800 mg every 8 h, 1000 mg every 12 h, or 1200 mg every 12 h. In a subsequent study (Study B), patients received indinavir at 800 mg every 8 h or 1200 mg every 12 h. All subjects received zidovudine (300 mg) and lamivudine (150 mg) every 12 h. An intent-to-treat analysis was used. In Study A, which enrolled 88 patients, neither HIV-1 RNA nor CD4 cell responses differed significantly between treatment groups at 24 weeks when corrected for multiple comparisons. Study B enrolled 433 patients, but was prematurely discontinued when interim analysis suggested greater efficacy of three-times-daily indinavir. Of the first 87 patients reaching week 24, HIV-1 RNA was less than 400 copies/ml in 91% receiving three-times-daily versus 64% receiving two-times-daily indinavir (P < 0.01). Three-times-daily indinavir appears more efficacious than two-times-daily dosing when administered with zidovudine and lamivudine. Two-times-daily indinavir dosing should only be considered in situations characterized by favorable pharmacokinetic drug-drug interactions.
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1Anti-HIV Agents - adverse effects
2Anti-HIV Agents - therapeutic use
3Antibiotics. Antiinfectious agents. Antiparasitic agents
4antiretroviral therapy
5Antiretroviral Therapy, Highly Active
6Antiviral agents
7Biological and medical sciences
8CD4 Lymphocyte Count
9clinical trial
10Drug Administration Schedule
11HIV infection
12HIV Infections - drug therapy
13HIV Infections - virology
14HIV protease inhibitors
15HIV-1 - isolation & purification
16HIV-1 - physiology
17Human immunodeficiency virus 1
18Humans
19indinavir
20Indinavir - administration & dosage
21Indinavir - adverse effects
22Indinavir - therapeutic use
23lamivudine
24Lamivudine - adverse effects
25Lamivudine - therapeutic use
26Medical sciences
27Pharmacology. Drug treatments
28Pilot Projects
29Reverse Transcriptase Inhibitors - adverse effects
30Reverse Transcriptase Inhibitors - therapeutic use
31RNA, Viral - blood
32Treatment Outcome
33Viral Load
34zidovudine
35Zidovudine - adverse effects
36Zidovudine - therapeutic use
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2BENETUCCI, Jorge
3CAHN, Pedro
4PAAR, David
5WHITE, A. Clinton
6COLLIER, Ann C
7RAMIREZ-RONDA, Carlos H
8HARVEY, Charlotte
9CHUNG, Mi-Ok
10MEHROTRA, Devan
11CHODAKEWITZ, Jeffrey
12THOMPSON, Melanie A
13NGUYEN, Bach-Yen
14PEDRO, Rogiero De
15GALLANT, Joel E
16UIP, David E
17CURRIER, Judith
18NORIEGA, L. Miguel
19LEWI, David S
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titleComparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine
authorHAAS, David W ; ARATHOON, Eduardo ; BENETUCCI, Jorge ; CAHN, Pedro ; PAAR, David ; WHITE, A. Clinton ; COLLIER, Ann C ; RAMIREZ-RONDA, Carlos H ; HARVEY, Charlotte ; CHUNG, Mi-Ok ; MEHROTRA, Devan ; CHODAKEWITZ, Jeffrey ; THOMPSON, Melanie A ; NGUYEN, Bach-Yen ; PEDRO, Rogiero De ; GALLANT, Joel E ; UIP, David E ; CURRIER, Judith ; NORIEGA, L. Miguel ; LEWI, David S ; URIBE, Patricia
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1Anti-HIV Agents - adverse effects
2Anti-HIV Agents - therapeutic use
3Antibiotics. Antiinfectious agents. Antiparasitic agents
4antiretroviral therapy
5Antiretroviral Therapy, Highly Active
6Antiviral agents
7Biological and medical sciences
8CD4 Lymphocyte Count
9clinical trial
10Drug Administration Schedule
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12HIV Infections - drug therapy
13HIV Infections - virology
14HIV protease inhibitors
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16HIV-1 - physiology
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30Reverse Transcriptase Inhibitors - therapeutic use
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32Treatment Outcome
33Viral Load
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35Zidovudine - adverse effects
36Zidovudine - therapeutic use
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4PAAR, David
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7RAMIREZ-RONDA, Carlos H
8HARVEY, Charlotte
9CHUNG, Mi-Ok
10MEHROTRA, Devan
11CHODAKEWITZ, Jeffrey
12THOMPSON, Melanie A
13NGUYEN, Bach-Yen
14PEDRO, Rogiero De
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17CURRIER, Judith
18NORIEGA, L. Miguel
19LEWI, David S
20URIBE, Patricia
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1ARATHOON, Eduardo
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8HARVEY, Charlotte
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atitleComparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine
jtitleAIDS (London)
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date2000
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volume14
issue13
spage1973
epage1978
pages1973-1978
issn0269-9370
eissn1473-5571
abstractTo compare the efficacy and safety of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine. Two multicenter, open-label, randomized 24-week studies. Adults HIV-1 infection, HIV-1 RNA greater than 10000 copies/ml, and no prior lamivudine or protease inhibitor therapy were eligible. In a pilot study (Study A), patients received indinavir at 800 mg every 8 h, 1000 mg every 12 h, or 1200 mg every 12 h. In a subsequent study (Study B), patients received indinavir at 800 mg every 8 h or 1200 mg every 12 h. All subjects received zidovudine (300 mg) and lamivudine (150 mg) every 12 h. An intent-to-treat analysis was used. In Study A, which enrolled 88 patients, neither HIV-1 RNA nor CD4 cell responses differed significantly between treatment groups at 24 weeks when corrected for multiple comparisons. Study B enrolled 433 patients, but was prematurely discontinued when interim analysis suggested greater efficacy of three-times-daily indinavir. Of the first 87 patients reaching week 24, HIV-1 RNA was less than 400 copies/ml in 91% receiving three-times-daily versus 64% receiving two-times-daily indinavir (P < 0.01). Three-times-daily indinavir appears more efficacious than two-times-daily dosing when administered with zidovudine and lamivudine. Two-times-daily indinavir dosing should only be considered in situations characterized by favorable pharmacokinetic drug-drug interactions.
copHagerstown, MD
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