3-year suppression of HIV viremia with indinavir, zidovudine, and lamivudine.
BACKGROUND
Antiretroviral regimens containing HIV protease inhibitors suppress viremia in HIV-infected patients, but the durability of this effect is not known.


OBJECTIVE
To describe the 3-year follow-up of patients randomly assigned to receive indinavir, zidovudine, and lamivudine in an ongoing clinical trial.


METHODS
Open-label extension of a randomized, double-blind study.


METHODS
Four clinical research units.


METHODS
33 HIV-infected, zidovudine-experienced patients with serum HIV RNA levels of at least 20,000 copies/mL and CD4 counts ranging from 50 to 400 cells/mm3.


METHODS
Indinavir, zidovudine, and lamivudine.


METHODS
Safety assessments, HIV RNA levels, CD4 cell counts, and genotypic analyses.


RESULTS
After 3 years of follow-up, 21 of 31 contributing patients (68% [95% CI, 49% to 83%]) had serum viral load levels less than 500 copies/mL. Twenty of 31 (65% [CI, 45% to 80%]) had levels less than 50 copies/mL. The median increase in CD4 count from baseline was 230 cells/mm3 (interquartile range, 150 to 316 cells/mm3). Nephrolithiasis occurred in 12 of 33 patients (36%).


CONCLUSIONS
A three-drug regimen of indinavir, zidovudine, and lamivudine suppressed viremia in two thirds of patients for at least 3 years.
Gulick
R M
RM
Weill Medical College of Cornell University, New York, New York, USA. rgulick@med.cornell.edu
Mellors
J W
JW
Havlir
D
D
Eron
J J
JJ
Meibohm
A
A
Condra
J H
JH
Valentine
F T
FT
McMahon
D
D
Gonzalez
C
C
Jonas
L
L
Emini
E A
EA
Chodakewitz
J A
JA
Isaacs
R
R
Richman
D D
DD
D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D006678:HIV / Q000235:genetics; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D019469:Indinavir / Q000009:adverse effects / Q000627:therapeutic use*; D007669:Kidney Calculi / Q000139:chemically induced; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D019562:Viral Load; D014766:Viremia / Q000188:drug therapy*; D015215:Zidovudine / Q000009:adverse effects / Q000627:therapeutic use*
D019380:Anti-HIV Agents; D012367:RNA, Viral; D019259:Lamivudine; D015215:Zidovudine; D019469:Indinavir