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Phase I trial with oral oxihumate in HIV-infected patients
Drug development research, 2002-09, Vol.57 (1), p.34-39
Botes, Mariëtte E.
Dekker, J.
van Rensburg, C.E.J.
2002
Volltextzugriff (PDF)
Details
Autor(en) / Beteiligte
Botes, Mariëtte E.
Dekker, J.
van Rensburg, C.E.J.
Titel
Phase I trial with oral oxihumate in HIV-infected patients
Ist Teil von
Drug development research, 2002-09, Vol.57 (1), p.34-39
Ort / Verlag
New York: Wiley Subscription Services, Inc., A Wiley Company
Erscheinungsjahr
2002
Quelle
Wiley-Blackwell Journals
Beschreibungen/Notizen
Oxihumate is formed through conversion of bituminous coal by controlled wet oxidation. The objective of the study, based on in vitro studies, was to evaluate the safety and toxicity profile of oxihumate at various doses in HIV‐1‐infected individuals. Thirty‐seven antiretroviral‐naïve adults were randomized in a double‐blind study to dosages of either 2, 4, 6, or 8 g oxihumate or placebo per day and treated for 2 weeks. The baseline CD4‐positive lymphocyte count was 213–570×106/L and baseline viral load 675–275,000 copies/ml. Patients were reviewed at days 5, 10, and 15, as well as 1 week posttreatment. Of the 37 patients, 35 were followed up until the end of the study. None of the adverse events was thought to be related to the investigative drug. Efficacy parameters were compared between treatment groups at week 2 using analysis of covariance (with baseline value for a patient as the covariant). Strong evidence (P=0.018) was found that the posttreatment weight differed between treatment groups (adjusted for initial weight). All active treatment groups gained weight compared to the placebo. No significant difference in the viral load or CD4‐positive lymphocyte count between the active ingredient and the placebo was found. None of the biochemical and hematological parameters differed significantly from the baseline at end of treatment. In conclusion, oxihumate is well tolerated, with an excellent safety profile when tested over a period of 2 weeks. This period was too short to establish efficacy or optimum dosage levels. Drug Dev. Res. 57:34–39, 2002. © 2002 Wiley‐Liss, Inc.
Sprache
Englisch
Identifikatoren
ISSN: 0272-4391
eISSN: 1098-2299
DOI: 10.1002/ddr.10117
Titel-ID: cdi_crossref_primary_10_1002_ddr_10117
Format
–
Schlagworte
Antibiotics. Antiinfectious agents. Antiparasitic agents
,
Antiviral agents
,
Biological and medical sciences
,
HIV
,
Medical sciences
,
oxihumate
,
Pharmacology. Drug treatments
,
phase I trial
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