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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00005918 |
The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).
Condition | Intervention | Phase |
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HIV Infections |
Drug: Efavirenz Drug: Lamivudine Drug: Stavudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | The Safety and Antiviral Efficacy of Stavudine Extended Release Formulation as Compared to Stavudine Immediate Release Formulation, Each as Part of Potent Antiretroviral Combination Therapy |
Estimated Enrollment: | 730 |
Study Start Date: | June 2000 |
Patients are randomized to receive blinded stavudine extended release (d4T ER) or immediate release (d4T IR) formulation. Randomization is balanced by screening HIV viral load of less than 30,000 copies/ml or at least 30,000 copies/ml and by site. Patients also receive open-label efavirenz (EFV) and lamivudine (3TC). Efficacy is evaluated over 48 weeks of the dosing period and safety is evaluated over the entire dosing period (56 weeks).
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Study ID Numbers: | 244F, AI455-099 |
Study First Received: | June 15, 2000 |
Last Updated: | October 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00005918 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination Stavudine Lamivudine RNA, Viral Dosage Forms |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load efavirenz |
Antimetabolites Efavirenz Sexually Transmitted Diseases, Viral Stavudine Anti-HIV Agents Acquired Immunodeficiency Syndrome Lamivudine Antiviral Agents |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Stavudine Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
Efavirenz RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |