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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 |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Zidovudine |
| 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 | |||||
| Merck Sharp and Dohme Research Laboratories |
| National Institute of Allergy and Infectious Diseases (NIAID) |
| Study Chair: | RT Schooley |
More Information
Click here for more information about Zidovudine 
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Kuritzkes DR, Curtis S, Rosandich M, Stein DS, Schooley RT. Delayed emergence of resistance to L-697,661 in patients receiving concomitant zidovudine. The ACTG 184 Study Team. Int Conf AIDS. 1993 Jun 6-11;9(1):467 (abstract no PO-B26-1994)
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Schooley RT, Campbell TB, Kuritzkes DR, Blaschke T, Stein DS, Rosandich ME, Phair J, Pottage JC, Messari F, Collier A, Kahn J. Phase 1 study of combination therapy with L-697,661 and zidovudine. The ACTG 184 Protocol Team. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Aug 1;12(4):363-70.
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Campbell TB, Routh JA, Bakhtiari M, Schooley RT, Kuritzkes DR. Detection of genotypic changes in reverse transcriptase during combination therapy with zidovudine and L-697,661. Detection of genotypic changes in reverse transcriptase during combination therapy with zidovudine and L-697,661. Int Conf AIDS. 1993 Jun 6-11;9(1):239 (abstract no PO-A26-0630)
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| Study ID Numbers: | ACTG 184, Merck Protocol 020-00 |
| First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000628 |
| Health Authority: | Unspecified |
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