Showing papers by "AIDS Clinical Trials Group published in 2001"
University of Rochester1, Harvard University2, Icahn School of Medicine at Mount Sinai3, Stanford University4, University of California, Los Angeles5, University of California, San Francisco6, University of Washington7, Cornell University8, Northwestern University9, Case Western Reserve University10, National Institutes of Health11, AIDS Clinical Trials Group12, Washington University in St. Louis13, Johns Hopkins University14
TL;DR: The authors investigated the long-term effect of the neurotrophin nerve growth factor (NGF) in an open-label study of 200 subjects with HIV-associated DSP and showed that NGF was safe and well tolerated and significantly improved pain symptoms.
Abstract: HIV-associated distal sensory polyneuropathy (DSP) is a common complication of AIDS. No effective treatment is available. The authors investigated the long-term effect (48 weeks) of the neurotrophin nerve growth factor (NGF) in an open-label study of 200 subjects with HIV-associated DSP. Similar to their previously reported double-blind study, the authors showed that NGF was safe and well tolerated and significantly improved pain symptoms. However, there was no improvement of neuropathy severity as assessed by neurologic examination, quantitative sensory testing, and epidermal nerve fiber density.
104 citations
TL;DR: Switching to IDV + ddI + d4T + HU in patients treated withIDV + ZDV + 3TC was associated with a worse outcome, principally because of drug toxicity.
Abstract: Background: Virologic rebound can result from suboptimal antiviral potency in combination antiretroviral therapy. Design: Multicenter, partially blinded, prospective, randomized study of 202 HIV-infected subjects to determine whether therapy intensification improves long-term rates of virologic suppression. Methods: Subjects had plasma HIV RNA 200 X 10 6 cells/I, and treatment with indinavir (IDV) + zidovudine (ZDV) + lamivudine (3TC) for at least 6 months before randomization to stay on this regimen or to receive IDV + didanosine (ddl) + stavudine (d4T) plus or minus hydroxyurea (HU) (600 mg twice daily). Treatment failure was defined as either confirmed rebound of HIV RNA level to > 200 copies/ml or a drug toxicity necessitating treatment discontinuation. Results: Treatment failure occurred more frequently in subjects randomized to the HU-containing arm (32.4%), than in those taking IDV + ddl + d4T (17.6%) or IDV + ZDV + 3TC (7.6%). The time to treatment failure was shorter for the HU-containing arm compared with the IDV + ZDV + 3TC (P < 0.0001) or IDV + ddl + d4T arms (P= 0.032). Dose-limiting toxicities rather than virologic rebound accounted for the differences between treatment failure among the study arms. Pancreatitis led to treatment discontinuation in 4% of subjects in treatment arms containing ddl + d4T. Three subjects with pancreatitis died, all randomized to the HU-containing arm. Conclusions: Switching to IDV + ddl + d4T + HU in patients treated with IDV + ZDV + 3TC was associated with a worse outcome, principally because of drug toxicity.
74 citations