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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Purpose
To assess the safety and tolerance of multiple oral doses of 141W94 alone, in combination with 1592U89, and in combination with Retrovir and Epivir, administered to patients with HIV infection as measured by the development of clinical adverse experiences and laboratory test abnormalities. To determine the steady-state pharmacokinetics of 141W94 alone and in combination with 1592U89 after multiple oral dosing. To obtain preliminary evidence of antiretroviral activity of 141W94 alone and in combination with 1592U89, the antiretroviral effect of combined Retrovir/Epivir and the antiretroviral effect of 141W94 when added to Retrovir/Epivir or to 1592U89/Retrovir/Epivir.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Abacavir sulfate Drug: Amprenavir Drug: Lamivudine Drug: Zidovudine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study 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 |
| Estimated Enrollment: | 60 |
60 HIV-infected patients will be sequentially assigned to receive 1 of 5 doses of 141W94 alone or 141W94 plus 1592U89. After each patient has completed 4 weeks of the assigned regimen (Phase A), the patient will receive Epivir and Retrovir for up to 8 months (Phase B). Patients originally assigned, in Phase A, to receive 141W94 and 1592U89 continue to receive 1592U89 during this period. Upon termination of Phase B, 141W94 is added to existing regimens of Phase B (Phase C). Phase C will last for 12 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| 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 | |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00002183 History of Changes |
| Other Study ID Numbers: | 264B |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
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:
|
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 Antiviral Agents Zidovudine Lamivudine Amprenavir |
Abacavir HIV Protease Inhibitors Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Anti-HIV Agents Protease Inhibitors Antibiotics, Antitubercular Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 19, 2013