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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
Show 22 Study Locations 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 |
