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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00005018 |
Purpose
The purpose of this study is to see if it is safe and effective to give HIV-positive patients a combination of anti-HIV drugs (abacavir [ABC] plus efavirenz [EFV] plus didanosine [ddI]) with and without hydroxyurea (HU).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Hydroxyurea Drug: Abacavir sulfate Drug: Efavirenz Drug: Didanosine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Phase IV 48-Week, Randomized, Open-Label, Multicenter Trial of Abacavir (300mg BID)/Efavirenz (600mg QD)/Didanosine (400mg QD) +/- Hydroxyurea (500mg BID) in HIV-1 Infected Subjects Failing Initial Therapy With 3TC/ZDV (or d4T) +/- Protease Inhibitor(s) |
| Estimated Enrollment: | 150 |
| Study Start Date: | July 1999 |
| Estimated Study Completion Date: | October 2000 |
Patients are randomized into one of two treatment arms: ABC/EFV/ddI or ABC/EFV/ddI/HU. In the second treatment arm, patients are further randomized to receive HU beginning at Baseline, when ABC/EFV/ddI is started, or at Week 8. Delaying HU may help offset the cytopenic effect of HU, as reflected in a blunted CD4 cell response. Patients are stratified according to their screening plasma HIV-1 RNA level (400 to 10,000 copies/ml and more than 10,000 to 100,000 copies/ml). Participants in the study receive study-related exams, lab tests, and study medications at no cost over the 48-week treatment period. The safety and effectiveness of the non-protease inhibitor rescue therapy is evaluated routinely by measuring viral load and the CD4 cell count, as well as the side effects caused by the medications. All of the medications are approved by the FDA and are not considered investigational.
Eligibility| Ages Eligible for Study: | 13 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:
Contacts and Locations| United States, California | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| Pacific Oaks Research | |
| Beverly Hills, California, United States, 90211 | |
| Altamed Medical Health Services | |
| Los Angeles, California, United States, 90022 | |
| St Lukes Medical Group | |
| San Diego, California, United States, 92101 | |
| Pacific Horizons Med Group | |
| San Francisco, California, United States, 94115 | |
| United States, Florida | |
| Gary Richmond MD | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| Saint Josephs Comprehensive Research Institute | |
| Tampa, Florida, United States, 33607 | |
| United States, Illinois | |
| Northstar Med Clinic | |
| Chicago, Illinois, United States, 60657 | |
| United States, Kentucky | |
| Univ of Kentucky Med Ctr | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Massachusetts | |
| Boston Med Ctr / Evans - 556 | |
| Boston, Massachusetts, United States, 021182393 | |
| CRI of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| United States, Nebraska | |
| Univ of Nebraska Medical Ctr | |
| Omaha, Nebraska, United States, 681985400 | |
| United States, New York | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10019 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Univ of North Carolina / Infectious Disease Division | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Univ of NC Infectious Diseases | |
| Wilmington, North Carolina, United States, 28402 | |
| United States, Pennsylvania | |
| Anderson Clinical Research Inc | |
| Reading, Pennsylvania, United States, 19604 | |
| United States, Rhode Island | |
| Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| Burnside Clinic | |
| Columbia, South Carolina, United States, 29206 | |
| United States, Texas | |
| Univ of Texas Med Branch | |
| Galveston, Texas, United States, 77555 | |
| Univ of Texas / Thomas Street Clinic | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Hampton Roads Med Specialists | |
| Hampton, Virginia, United States, 23666 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00005018 History of Changes |
| Other Study ID Numbers: | 238R, NZTA4008 |
| Study First Received: | April 4, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Didanosine Drug Therapy, Combination Zidovudine Stavudine HIV Protease Inhibitors Hydroxyurea |
RNA, Viral Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load abacavir 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 Didanosine Reverse Transcriptase Inhibitors Efavirenz Abacavir |
Anti-HIV Agents Hydroxyurea Protease Inhibitors HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Antineoplastic Agents Antisickling Agents |
