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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001067 |
To determine drug efficacy and safety in HIV-infected patients treated with zidovudine ( AZT ) versus stavudine ( d4T ) versus both drugs. Also, to compare short- and long-term changes in magnitude of HIV RNA over time.
Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Lamivudine Drug: Stavudine Drug: Zidovudine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Randomized Study of the Virologic and Immunologic Effects of Zidovudine Plus Lamivudine (3TC) Versus d4T Versus Zidovudine Plus d4T in HIV-Infected Patients With CD4 Cell Counts Between 300-600/mm3 and No Previous Nucleoside Experience |
Estimated Enrollment: | 105 |
Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option.
Patients are randomized to receive d4T alone, AZT alone, or both in combination for at least 12 weeks. After week 12, 3TC is added to the combination arm. Treatment continues for up to 48 weeks (was a total of 48 weeks, amended 3/26/96).
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 921036325 | |
Stanford Univ Med Ctr | |
Stanford, California, United States, 943055107 | |
United States, Connecticut | |
Yale Univ / New Haven | |
New Haven, Connecticut, United States, 065102483 | |
United States, District of Columbia | |
Howard Univ | |
Washington, District of Columbia, United States, 20059 | |
United States, Georgia | |
Emory Univ | |
Atlanta, Georgia, United States, 30308 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
State of MD Div of Corrections / Johns Hopkins Univ Hosp | |
Baltimore, Maryland, United States, 212052196 | |
United States, Missouri | |
St Louis Regional Hosp / St Louis Regional Med Ctr | |
St Louis, Missouri, United States, 63112 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
SUNY / Health Sciences Ctr at Brooklyn | |
Brooklyn, New York, United States, 112032098 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
Duke Univ Med Ctr | |
Durham, North Carolina, United States, 277103499 | |
United States, Ohio | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 | |
United States, Texas | |
Univ of Texas Galveston | |
Galveston, Texas, United States, 775550435 | |
Puerto Rico | |
Univ of Puerto Rico | |
San Juan, Puerto Rico, 009365067 |
Study Chair: | Havlir D | |
Study Chair: | Pollard R | |
Study Chair: | Richman D | |
Study Chair: | Friedland G |
Study ID Numbers: | ACTG 298 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00001067 |
Health Authority: | United States: Federal Government |
Drug Therapy, Combination AIDS-Related Complex Zidovudine Stavudine Lamivudine |
Virus Diseases Sexually Transmitted Diseases, Viral Stavudine HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Lamivudine Zidovudine AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |