|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00002227 History of Changes |
| Other Study ID Numbers: | 281C, DMP 266-043 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Stavudine Lamivudine Reverse Transcriptase Inhibitors efavirenz |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Stavudine Lamivudine |
Reverse Transcriptase Inhibitors Efavirenz Anti-HIV Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |