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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Page 1 of 1 (3 locations)

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