A Randomized Pilot Study of Alternating or Simultaneous Zidovudine and Didanosine Therapy in Patients with Symptomatic Human Immunodeficiency Virus Infection

• Published in: The Journal of infectious diseases Vol. 169; no. 1; pp. 9 - 17
• Main Authors: Yarchoan, Robert, Lietzau, Jill A., Nguyen, Bach-Yen, Brawley, Otis W., Pluda, James M., Saville, M. Wayne, Wyvill, Kathleen M., Steinberg, Seth M., Agbaria, Riad, Mitsuya, Hiroaki, Broder, Samuel
• Format: Journal Article
• Language: English
• Published: Chicago, IL The University of Chicago Press 01.01.1994; University of Chicago Press
• Subjects: Administration, Oral; Adolescent; Adult; AIDS; AIDS-Related Opportunistic Infections; Anti HIV agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antigens; Antiviral agents; beta 2-Microglobulin - analysis; Biological and medical sciences; Body Weight - drug effects; CD4-Positive T-Lymphocytes; Didanosine - administration & dosage; Didanosine - adverse effects; Didanosine - therapeutic use; Dosage; Drug Administration Schedule; Drug Therapy, Combination; Female; Follow-Up Studies; HIV; HIV Core Protein p24 - blood; HIV infections; HIV Infections - drug therapy; HIV Infections - immunology; human immunodeficiency virus; Humans; Infections; Leukocyte Count - drug effects; Major Articles; Male; Medical sciences; Middle Aged; Pancreatitis; Pancreatitis - chemically induced; Pharmacology. Drug treatments; Pilot Projects; Statistical significance; Viruses; Zidovudine - administration & dosage; Zidovudine - adverse effects; Zidovudine - therapeutic use; Infection; Human; Immunopathology; Drug combination; Chemotherapy; Treatment; Viral disease; Treatment efficiency; Antiviral; AIDS; Therapeutic protocol; Immune deficiency
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1093/infdis/169.1.9

A randomized pilot study comparing alternating and simultaneous regimens of zidovudine and didanosine (ddl) was conducted in 41 patients with AIDS or symptomatic human immunodeficiency virus (HIV) infection. Patients on each regimen received the same overall amounts of zidovudine and didanosine over time. CD4 cell counts in patients on the simultaneous regimen reached a maximum (mean ± SE) of 108 ± 16/mm3 above baseline (two-tailed P ⩾ .0001) and were significantly higher than in patients on the alternating regimen at all time points during weeks 6–45. At 54 weeks, the CD4 cell counts in the patients on the simultaneous regimen were still 40 ± 19/mm3 above baseline. Patients on the simultaneous regimen also had significantly greater weight gain. While toxicities were generally mild and comparable between the regimens, 1 patient on the simultaneous regimen died of pancreatitis and lactic acidosis. Thus, simultaneous therapy provided more sustained elevations in CD4 cells than alternating therapy over 1 year and may be worth exploring in larger controlled trials.