To determine drug efficacy and safety in HIV-infected patients treated with zidovudine ( AZT ) versus stavudine ( d4T ) versus both drugs. Also, to compare short- and long-term changes in magnitude of HIV RNA over time. Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option.
Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option. Patients are randomized to receive d4T alone, AZT alone, or both in combination for at least 12 weeks. After week 12, 3TC is added to the combination arm. Treatment continues for up to 48 weeks (was a total of 48 weeks, amended 3/26/96).
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
105
Alabama Therapeutics CRS
Birmingham, Alabama, United States
Stanford CRS
Palo Alto, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, United States
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Washington U CRS
St Louis, Missouri, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
...and 3 more locations
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