ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
Patients must have:
- HIV seropositivity.
- CD4 count <= 500 cells/mm3.
- NO active AIDS opportunistic infection.
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Other active intercurrent illness.
- Any condition possibly affecting drug absorption (e.g., ulcers, gastrectomy,
HIV-associated enteropathies.
- Signs or symptoms of severe illness that would preclude study participation.
- Known allergies to macrolide antibiotics.
Patients with the following prior condition are excluded:
Clinically important change in baseline status within 4 weeks prior to study entry.
Prior Medication:
Excluded:
- Investigational drugs including treatment IND drugs within 4 weeks prior to study
entry.
Known drug or alcohol dependence.
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | A Study of Azithromycin in HIV-Infected Patients | ||
| Official Title ICMJE | Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects | ||
| Brief Summary | To assess the dose proportionality of azithromycin concentrations and toleration when delivered in tablet formulation to HIV-infected patients. The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population. | ||
| Detailed Description | The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population. Patients are randomized to receive azithromycin at 1 of 2 doses in a two-treatment, two-period, cross-over study. Dosing visits are separated by at least 14-day wash-out periods. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 1 | ||
| Study Design ICMJE | Intervention Model: Parallel Assignment Primary Purpose: Treatment | ||
| Condition ICMJE |
| ||
| Intervention ICMJE | Drug: Azithromycin | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | 12 | ||
| Original Enrollment ICMJE | Same as current | ||
| Study Completion Date ICMJE | Not Provided | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Patients with the following prior condition are excluded: Clinically important change in baseline status within 4 weeks prior to study entry. Prior Medication: Excluded:
Known drug or alcohol dependence. | ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00002344 | ||
| Other Study ID Numbers ICMJE | 226C 066-060 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | NIH AIDS Clinical Trials Information Service | ||
| Verification Date | April 1996 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||