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| Sponsor: | Dupont Merck |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002227 |
Purpose
The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus lamivudine to patients who have never taken anti-HIV drugs.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Efavirenz Drug: Lamivudine Drug: Stavudine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Phase II, Open-Label, Multicenter Study to Characterize the Effectiveness and Safety of Efavirenz in Combination With Stavudine and Lamivudine in Antiretroviral Therapy-Naive HIV-Infected Patients |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine or any medications contraindicated for concomitant use with stavudine or lamivudine as described in the current information package insert.
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Risk Behavior:
Excluded:
Current alcohol or illicit drug use which interferes with patient's ability to follow study regimen.
Contacts and Locations| United States, District of Columbia | |
| Richard Elion | |
| Washington, District of Columbia, United States, 20009 | |
| The Whitman Walker Clinic | |
| Washington, District of Columbia, United States, 20009 | |
| United States, Massachusetts | |
| Community Research Initiative of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| United States, Ohio | |
| Remington Davis Inc | |
| Columbus, Ohio, United States, 43215 | |
| United States, Pennsylvania | |
| The Milton S Hersey Med Ctr / Div of Hematology | |
| Hershey, Pennsylvania, United States, 170330850 | |
| United States, South Carolina | |
| Coastal Carolina Research Ctr | |
| Mount Pleasant, South Carolina, United States, 29464 | |
| United States, Texas | |
| Montrose Clinic | |
| Houston, Texas, United States, 77006 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
More Information
| Study ID Numbers: | 281C, DMP 266-043 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002227 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Stavudine Lamivudine Reverse Transcriptase Inhibitors efavirenz |
|
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 |