Phase I trial with oral oxihumate in HIV-infected patients

✍ Scribed by Mariëtte E. Botes; J. Dekker; C.E.J. van Rensburg

• Publisher: John Wiley and Sons
• Year: 2002
• Tongue: English
• Weight: 89 KB
• Volume: 57
• Category: Article
• ISSN: 0272-4391
• DOI: 10.1002/ddr.10117

✦ Synopsis

Abstract

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 213–570×10^6^/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.