A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection
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ClinicalTrials.gov Identifier: NCT00002183 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Abacavir sulfate Drug: Amprenavir Drug: Lamivudine Drug: Zidovudine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 60 participants |
Primary Purpose: | Treatment |
Official Title: | A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Localized therapy such as intralesional injections for Kaposi's sarcoma.
Patients must have:
- HIV infection documented by a licensed HIV antibody ELISA confirmed by:
- Western blot, or positive HIV blood culture, or positive HIV serum antigen and second antibody test positive by a method other than ELISA.
-
CD4+ counts >= 150 and <= 400 cells/mm3 within 2 weeks of study entry.
1. Anticipated need for cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
- Alprazolam, carbamazepine, codeine, clarithromycin, dapsone, diazepam, diltiazem, erythromycin, estrogens, glucocorticoids, imipramine, itraconazole, ketoconazole, lidocaine, lovastatin, nifedipine, phenobarbital, phenytoin, quinidine, rifabutin, rifampin and warfarin.
- The following medications should be used with caution in most instances or not at all:
- terfenadine, astemizole, cisapride, triazolam and midazolam.
Anticipated need for treatment with radiation therapy within 4 weeks prior to entry.
1. Treatment with cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
- Patients who have previously received a protease inhibitor.
- Antiretroviral therapy within 2 weeks prior to enrollment.
NOTE:
- Patients with a known intolerance to either retrovir or epivir are not eligible for Phase B of this study.
NOTE:
- Patients with previous epivir (3TC) experience will not be eligible for Regimen 6 of this study (combination therapy with 141W94 and 1592U89).
- Treatment with immunomodulating agents, including but not limited to systemic corticosteroids, IL-2, alpha-IFN, beta-IFN, or gamma-IFN within 4 weeks prior to entry.
- Treatment with HIV immunotherapeutic vaccine within 3 months prior to entry. Treatment with radiation therapy within 4 weeks prior to entry. Patients with current alcohol or illicit drug use which, in the opinion of the principal investigator, may interfere with the patients' ability to comply with the dosing schedule and protocol evaluations.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002183
United States, California | |
UCSD | |
San Diego, California, United States, 92103 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 |
Publications:
ClinicalTrials.gov Identifier: | NCT00002183 History of Changes |
Other Study ID Numbers: |
264B |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | July 1997 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination Drug Administration Schedule HIV Protease Inhibitors VX 478 Anti-HIV Agents |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lamivudine Zidovudine |
Abacavir Amprenavir Antiviral Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents HIV Protease Inhibitors |