Tenofovir DF in antiretroviral-experienced patients: results from a 48-week, randomized, double-blind study
| Autor: | Harry Lampiris, Shan-Shan Chen, Peter Ruane, Robert A. Myers, Study Team, Michael D. Miller, Andrew K. Cheng, Robert T. Schooley, Daniel S Berger, Erica Isaacson, Gildon N. Beall |
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| Rok vydání: | 2002 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors medicine.medical_treatment Immunology Organophosphonates Renal function HIV Infections Placebo Gastroenterology law.invention Organophosphorus Compounds Double-Blind Method Randomized controlled trial law Internal medicine Drug Resistance Viral medicine Humans Immunology and Allergy Tenofovir Adverse effect Sida Chemotherapy biology business.industry Adenine Incidence (epidemiology) biology.organism_classification CD4 Lymphocyte Count Surgery Clinical trial Infectious Diseases HIV-1 RNA Viral Female business |
| Zdroj: | AIDS. 16:1257-1263 |
| ISSN: | 0269-9370 |
| DOI: | 10.1097/00002030-200206140-00008 |
| Popis: | OBJECTIVE To evaluate the safety and efficacy of once daily doses of tenofovir DF (TDF) administered in combination with other antiretroviral therapy (ART) in treatment-experienced HIV-1-infected patients with incomplete virological suppression. DESIGN One-hundred and eighty-nine subjects with plasma HIV-1 RNA levels between 400 and 100,000 copies/ml and stable ART (> or = 8 weeks) were randomized (2 : 2 : 2 : 1 ratio) to add TDF 75 mg, 150 mg, or 300 mg or placebo to existing ART in a double-blinded manner. After 24 weeks, patients initially randomized to placebo received blinded TDF 300 mg. METHODS Efficacy was analyzed by the mean changes HIV-1 RNA levels (log10 copies/ml plasma; DAVG(xx)) from week 0 to weeks 4, 24, and 48. Safety was analyzed by incidence of grade 3 or 4 clinical and laboratory adverse events. RESULTS At baseline, patients had mean 4.6 years prior ART use with 94% having HIV-1 with nucleoside-associated resistance mutations. There were statistically significant decreases in DAVG(4) and DAVG(24) for all doses of TDF compared with placebo, with the greatest effect seen with TDF 300 mg (DAVG(4), -0.62, P < 0.001; DAVG(24), -0.58; P < 0.001; DAVG(48), -0.62). The incidence of adverse events was similar among the TDF groups and placebo through week 24. Throughout the 48-week study, no significant changes in renal function were observed. CONCLUSIONS In treatment-experienced patients with baseline nucleoside resistance mutations, TDF provided dose-related, durable reductions in HIV-1 RNA. Through 24 weeks, the safety profile of TDF was similar to that of placebo. |
| Databáze: | OpenAIRE |
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