Search / Trial NCT00000962

The Safety and Effectiveness of BI-RG-587 in HIV-Infected Patients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Drug Evaluation Acquired Immunodeficiency Syndrome Aids Related Complex Nevirapine

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 advantages if it is active against AZT-resistant isolates. Nevirapine (BI-RG-587) has shown in vitro inhibitory activity against HIV-1 reverse transcriptase (RT). The molecular mechanism of the RT inhibitory effect is hypothesized to be non-competitive inhibition due to its binding to an RT site distinct from those for the RNA template primer, the deoxynucleotide triphosphate or the RNase H cata...

Gender

All

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.

Attachments

readout_NCT00000962_2024-07-23.pdf

4.5 MB

NCT00000962_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

San Diego, California, United States

Worcester, Massachusetts, United States

Minneapolis, Minnesota, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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