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| Sponsors and Collaborators: |
Merck Sharp and Dohme Research Laboratories National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000628 |
Purpose
Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661. L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: L-697,661 Drug: Zidovudine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine |
| Estimated Enrollment: | 27 |
L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
Part 1: Twelve patients are randomly assigned to one of two groups. Group 1 patients receive AZT for 7 days, followed by AZT plus L-697,661 with food for 56 days. Group 2 patients receive no drug for 7 days, followed by L-697,661 with food for 56 days. Antipyrine is administered 1 hour prior to study drug on days 8, 22, and 35. Part 2: Fifteen patients receive L-697,661 with food, for 8 weeks. Therapy with L-697,661 may be extended beyond 8 weeks for up to 24 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication: Included:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Patients in Part 2 only:
Excluded:
Risk Behavior:
Excluded:
Patients may not have the following prior conditions:
Contacts and Locations| United States, California | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| United States, Colorado | |
| Univ of Colorado Health Ctr / Denver Gen Hosp | |
| Denver, Colorado, United States, 80262 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 981224304 | |
| Study Chair: | RT Schooley |
More Information
| Study ID Numbers: | ACTG 184, Merck Protocol 020-00 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000628 History of Changes |
| Health Authority: | Unspecified |
|
Drug Evaluation Drugs, Investigational Drug Therapy, Combination |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents |
|
Antimetabolites Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine AIDS-Related Complex Antiviral Agents |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
|
Antimetabolites Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Zidovudine Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors |