Completed
Nevirapine and Clarithromycin Interaction in HIV+ Patients
What is being tested
Erythromycin
+ Nevirapine
+ Clarithromycin
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
From 18 to 65 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Summary
Principal SponsorBoehringer Ingelheim
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
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.
Principal SponsorBoehringer Ingelheim
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
4 inclusion criteria required to participate
Allowed: 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.
Allowed: Patients may be on clarithromycin at study entry.
Patients must have CD4 count >= 100 cells/mm3.
Patients must have HIV positive status.
10 exclusion criteria prevent from participating
Excluded: 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.
Excluded: Use of protease inhibitors; ritonavir, nelfinavir, indinavir, or non-nucleoside reverse transcriptase inhibitor compounds e.g., delavirdine) within 4 weeks of study entry.
Patients with a history of drug allergy or known drug hypersensitivity are excluded.
Patients with malabsorption, severe chronic diarrhea, or inability to maintain adequate oral intake are excluded.
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
South Florida Bioavailability Clinic
Miami, United StatesOpen South Florida Bioavailability Clinic in Google MapsCompletedOne Study Center