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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002320 |
Purpose
To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients.
PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Lamivudine Drug: Zidovudine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Randomized, Double-Blind Multicenter Trial to Compare the Safety and Efficacy of Lamivudine (3TC; GR109714X) Monotherapy Versus Zidovudine (AZT) Monotherapy Versus 3TC Administered With AZT in the Treatment of HIV-1 Infected Patients Who Are AZT Naive (< 4 Weeks) With CD4 Cell Counts of 200-500 Cells/mm3 |
| Estimated Enrollment: | 320 |
Patients are randomized to one of four treatment arms: 3TC alone, AZT alone, low-dose 3TC plus AZT, or high-dose 3TC plus AZT. Patients receive treatment for 32 weeks, with possible extension to 52 weeks.
PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Patients with the following prior condition are excluded:
History of intolerance to AZT.
Prior Medication:
Excluded:
Contacts and Locations
Hide Study Locations| United States, California | |
| Combat Group | |
| Los Angeles, California, United States, 90028 | |
| Pacific Oaks Med Group | |
| Sherman Oaks, California, United States, 91403 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90509 | |
| San Diego Community Research Group | |
| San Diego, California, United States, 92104 | |
| United States, Florida | |
| Infectious Disease Research Institute Inc | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Chicago Ctr for Clinical Research | |
| Chicago, Illinois, United States, 60607 | |
| United States, Louisiana | |
| Louisiana Cardiovascular Research Ctr | |
| New Orleans, Louisiana, United States, 70119 | |
| United States, Massachusetts | |
| CRI of New England | |
| Brookline, Massachusetts, United States, 02445 | |
| United States, New York | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10019 | |
| United States, North Carolina | |
| Univ of North Carolina School of Medicine | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| United States, Ohio | |
| Med College of Ohio | |
| Toledo, Ohio, United States, 43699 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 97210 | |
| United States, Rhode Island | |
| Mem Hosp of Rhode Island | |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, Texas | |
| Nicholaos Bellos | |
| Dallas, Texas, United States, 75246 | |
| Central Texas Med Foundation | |
| Austin, Texas, United States, 78751 | |
| United States, Virginia | |
| Richmond AIDS Consortium | |
| Richmond, Virginia, United States, 23219 | |
| United States, Wisconsin | |
| Wisconsin Community - Based Research Consortium | |
| Milwaukee, Wisconsin, United States, 53202 | |
| Canada, Ontario | |
| Ottawa General Hospital | |
| Ottawa, Ontario, Canada | |
| Toronto Hosp | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Montreal Gen Hosp | |
| Montreal, Quebec, Canada | |
| Puerto Rico | |
| Advance Community Health Services Inc | |
| Santurce, Puerto Rico, 00908 | |
More Information
| Study ID Numbers: | 129B, NUCA 3001 |
| Study First Received: | November 2, 1999 |
| Last Updated: | December 8, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002320 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents Zidovudine |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
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 |
