Status:
COMPLETED
The Safety and Effectiveness of BI-RG-587 in HIV-Infected Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To assess the safety and tolerance of multiple oral doses of Nevirapine (BI-RG-587). To generate data on the pharmacokinetics and dose proportionality of Nevirapine with multiple dosing. To characteri...
Detailed Description
A compound free of the toxic effects of nucleoside chain terminators such as zidovudine (AZT) may have an advantage over currently available treatments for HIV infection. Such a compound has further a...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Pentamidine or dapsone prophylaxis for Pneumocystis carinii pneumonia (PCP) in patients with a CD4+ cell count = or < 200 cells/mm3.
- Antifungal prophylaxis with oral fluconazole or ketoconazole.
- Antiviral prophylaxis with a maximum of 1 gram of oral acyclovir per day.
- Acute therapy for intercurrent infections so long as that therapy is not an excluded medication of an excluded opportunistic infection.
Patients must have:
- Positive HIV antibody test results by ELISA.
- Average of CD4+ cell count at 60 and at 21 days prior to study beginning = or < 400 cells/mm3.
- Seven of 10 patients in each treatment arm must have p24 antigen levels = or > 70 pg/ml (> 50 pg/ml at U. of Mass. site only) or be plasma viremic.
- Preserved hematologic, hepatic, and renal function as defined by required lab values.
- Ambulatory performance score of = or > 70 Karnofsky.
- Ability to voluntarily provide written informed consent prior to treatment.
- Willingness and ability to follow protocol requirements.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Active cytomegalovirus disease.
- Toxoplasmic encephalitis requiring suppressive therapy.
- Mycobacteriosis requiring maintenance chemotherapy.
- Visceral Kaposi's sarcoma requiring chemotherapy and/or irradiation.
- Malignancy other than Kaposi's sarcoma or limited cutaneous basal cell carcinoma.
- More than mild diarrhea (defined as more than transient or > 4 loose stools per day).
Concurrent Medication:
The following medications / substances may NOT be ingested up to one hour before or 4 hours after a Nevirapine dose:
- Antacids (particularly those containing calcium carbonate).
- Cimetidine.
- Carafate.
- Cholestyramine resin.
- Alcohol and alcohol-containing substances.
- Benzodiazepines (diazepam, triazolam).
Excluded:
- Any approved or investigational antiretroviral, immunosuppressive, or cytotoxic drugs.
- Glucocorticoids and steroid hormones (including oral contraceptives).
- Dicumarol, warfarin, and other anticoagulant medications.
- Nitroglycerin.
- Digitoxin.
- Valproic acid.
- Tolbutamide.
- Doxycycline.
- Chloramphenicol.
- Isoniazid.
- Any sulfonamide medications.
Patients with the following are excluded:
- History of clinically important disease other than HIV infection defined by the investigator as possibly putting the patient at risk during study participation.
- Conditions listed in Exclusion Co-Existing Conditions and symptoms.
- Having received any approved or investigational antiretroviral, immunosuppressive, or cytotoxic drugs or any other experimental drug with 4 weeks of study entry.
- A positive zidovudine (AZT) detection assay performed 7 days prior to drug dosing will exclude patients from study participation.
Prior Medication:
Excluded within 4 weeks of study entry:
- Any approved or investigational antiretroviral, immunosuppressive or cytotoxic drugs.
- Glucocorticoids and steroid hormones (including oral contraceptives).
- Dicumarol, warfarin, and other anticoagulant drugs.
- Nitroglycerin. Digitoxin.
- Valproic acid.
- Tolbutamide.
- Doxycycline.
- Chloramphenicol.
- Isoniazid.
- Antiepileptics (phenobarbital and other barbiturates).
- Trimethoprim / sulfamethoxazole (Bactrim).
Risk Behavior:
Excluded:
- Patients whose use of alcohol or drugs is sufficient to impair compliance with protocol requirements.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00000962
Last Update
August 4 2008
Active Locations (3)
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1
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
2
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
3
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455