Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy
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ClinicalTrials.gov Identifier: NCT00312832 |
Recruitment Status
:
Completed
First Posted
: April 11, 2006
Last Update Posted
: October 24, 2006
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Lipoatrophy | Drug: switching; dose reduction | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | January 2004 |
Study Completion Date : | February 2005 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312832
Principal Investigator: | Jose Maria Gatell | Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT00312832 History of Changes |
Other Study ID Numbers: |
D40-30 |
First Posted: | April 11, 2006 Key Record Dates |
Last Update Posted: | October 24, 2006 |
Last Verified: | January 2004 |
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 |