Effect of stavudine on human immunodeficiency virus type 1 virus load as measured by quantitative mononuclear cell culture, plasma RNA, and immune complex-dissociated antigenemia.

Author(s): Griffith BP, Brett-Smith H, Kim G, Mellors JW, Chacko TM, Garner RB, Cheng YC, Alcabes P, Friedland G

Affiliation(s): Department of Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.

Publication date & source: 1996-05, J Infect Dis., 173(5):1252-5.

Publication type: Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Randomized Controlled Trial

The antiviral effect of stavudine (2', 3'-didehydro-3'-deoxythymidine) against human immunodeficiency virus (HIV) type 1 was measured in 15 HIV-infected patients at baseline and at weeks 4, 10, 22, 34, and 52 of therapy. Patients received 0.1, 0.5, 1.0, or 2.0 mg/kg/day of stavudine. At all time points examined during the 52 weeks of therapy, the median virus titers in peripheral blood mononuclear cells were decreased 1-2 logs, and median immune complex-dissociated antigen levels were reduced 37%-67% compared with baseline values. Plasma RNA content measured by polymerase chain reaction was reduced approximately 0.5 log from baseline median values at both time points examined (weeks 10 and 52). These data demonstrate that stavudine has a substantial and durable antiviral effect.