|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002199 |
Purpose
To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC, defined class B/C events, survival, medical resource utilization, and the development of plasma viral genotypic and phenotypic resistance.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety Study |
| Official Title: | A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects. |
| Estimated Enrollment: | 550 |
In this international study, 550 patients are randomized (225 per arm) to receive Combivir in combination with 1592U89 or indinavir. If after 16 weeks (and every 8 weeks thereafter until week 48) a patient has HIV-1 RNA >= 400 copies/ml (by PCR on two occasions >= 1 week and < 4 weeks apart), the patient has the option to switch to open-label therapy consisting of indinavir, 1592U89, and Combivir.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
GM-CSF, G-CSF, and erythropoietin.
Concurrent Treatment:
Allowed:
Local treatment for Kaposi's sarcoma.
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
History of relevant pancreatitis or hepatitis in the last 6 months.
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Radiation therapy within 30 days of study drug administration.
Current alcohol or illicit drug use that may interfere with patient compliance.
Contacts and Locations
More Information
| Study ID Numbers: | 238K, CNAA/B3005 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002199 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Drug Therapy, Combination Zidovudine Drug Resistance, Microbial HIV Protease Inhibitors Lamivudine |
Indinavir Genotype Phenotype Reverse Transcriptase Inhibitors Anti-HIV Agents abacavir |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Abacavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |