Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy
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Purpose
Background: Stavudine-containing regimens are associated with a potential for lipoatrophy and dyslipidemia. We assessed the safety and efficacy of reducing the dose of stavudine compared to switching to tenofovir or maintaining the standard dose of stavudine.
Methods: Clinically stable lipoatrophic HIV-infected patients receiving antiretroviral therapy containing stavudine 40 mg bid with a plasma HIV RNA <200 copies/mL for at least 6 months were randomized to maintain stavudine 40 mg bid (d4T40 arm), to reduce to 30 mg bid (d4T30 arm), or to switch from stavudine to tenofovir-DF (TDF arm) while preserving the remaining drugs. Fasting metabolic parameters were assessed at baseline and at weeks 4, 12, and 24. Mitochondrial parameters in peripheral blood mononuclear cells and body composition were measured at baseline and at week 24.
| Condition | Intervention |
|---|---|
|
HIV Infections Lipoatrophy |
Drug: switching; dose reduction |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Open Label Study Comparing the Impact of Reducing the Dose of Stavudine Versus Switching to Tenofovir on Plasma Lipids, Body Composition and Mitochondrial Function in HIV-Infected Patients Receiving Antiretroviral Therapy |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study eligibility criteria included documented HIV infection, age 18 years or older, moderate to severe clinical lipoatrophy in at least one region upon physical examination (17,18), viral load <200 copies/mL for at least 6 months prior to inclusion in the study, and a stable triple antiretroviral therapy including d4T 40 mg bid for at least the 6 preceding months, and no prior TDF use.
Exclusion Criteria:
Prior TDF use, viral load>200 copies.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00312832
| Principal Investigator: | Jose Maria Gatell | Hospital Clinic of Barcelona |
More Information
| ClinicalTrials.gov Identifier: | NCT00312832 History of Changes |
| Other Study ID Numbers: | D40-30 |
| Study First Received: | April 7, 2006 |
| Last Updated: | October 23, 2006 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Clinic of Barcelona:
|
HIV d4T TDF |
lipoatrophy treatment experienced HIV-infection |
Additional relevant MeSH terms:
|
HIV Infections Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders |
Metabolic Diseases Tenofovir Stavudine Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Antimetabolites |
ClinicalTrials.gov processed this record on September 23, 2016