Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 2002
To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin, and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.

Condition Intervention Phase
HIV Infections
Drug: Erythromycin
Drug: Nevirapine
Drug: Clarithromycin
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 36
Detailed Description:

The study is conducted in two separate groups. Patients in Group I receive clarithromycin orally for 32 days and nevirapine orally for 28 days.

Patients in Group II receive erythromycin intravenously on days 0, 14, 28, and 43 and nevirapine orally for 28 days.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


Antiretroviral drugs (i.e., zidovudine, zalcitabine, stavudine, lamivudine, didanosine, indinavir, saquinavir) provided that there has been no change in dosing of the medication > 25% within 4 weeks of study entry.

Patients must have:

  • HIV positive status.
  • CD4 count >= 100 cells/mm3.

Prior Medication:


Patients may be on clarithromycin at study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

Malabsorption, severe chronic diarrhea, or inability to maintain adequate oral intake.

Concurrent Medication:


Macrolide antibiotics (erythromycin, azithromycin, dirithromycin), azole fungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, phenytoin, terfenadine, astemizole, cisapride, triazolam, midazolam, other non-nucleoside reverse transcriptase inhibitors, antibiotics containing clavulanic acid, and Augmentin.

Patients with the following prior conditions are excluded:

  • History of drug allergy or known drug hypersensitivity.
  • History of clinically important disease including hepatic, renal, cardiovascular, or gastrointestinal disease.

Prior Medication:


  • Investigational drugs or antineoplastic agents within 12 weeks of study entry.
  • Participation in a clinical trial that used ERMBY within one year of study entry.
  • Systemic treatment with drugs known to be potent hepatic enzyme inducers or inhibitors (e.g., oral macrolide antibiotics, azole antifungals, cimetidine, rifampin, rifabutin, and carbamazepine) within 28 days of study entry.
  • Use of protease inhibitors; ritonavir, nelfinavir, indinavir, or non-nucleoside reverse transcriptase inhibitor compounds e.g., delavirdine) within 4 weeks of study entry.

Prior Treatment:


Radiotherapy within 12 weeks of study entry.

Risk Behavior:


Current history (within the last year) of IVDA, ETOH, or substance abuse.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002194

United States, Florida
South Florida Bioavailability Clinic
Miami, Florida, United States, 331813405
Sponsors and Collaborators
Boehringer Ingelheim
  More Information Identifier: NCT00002194     History of Changes
Other Study ID Numbers: 200G
Study First Received: November 2, 1999
Last Updated: June 23, 2005

Keywords provided by NIH AIDS Clinical Trials Information Service:
Antibiotics, Macrolide
Reverse Transcriptase Inhibitors
Cytochrome P-450
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Erythromycin stearate
Erythromycin Estolate
Erythromycin Ethylsuccinate
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on May 22, 2017