Completed

Azithromycin's Safety and Efficacy in Treating Cryptosporidiosis in AIDS Patients

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Study Aim

This study aims to evaluate the safety and effectiveness of Azithromycin in treating Cryptosporidiosis in patients living with AIDS.

What is being tested

Azithromycin

Drug
Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on finding a treatment for intestinal cryptosporidial infection in patients with Acquired Immune Deficiency Syndrome (AIDS). The goal is to evaluate the safety and effectiveness of a drug called azithromycin in managing this condition. This research is important as it aims to improve the care and quality of life for AIDS patients suffering from intestinal cryptosporidial infection, a common complication of AIDS. During the study, participants receive either azithromycin or a placebo, a substance that looks like the drug but contains no active medication. This is a double-blind study, meaning neither the participants nor the researchers know who is receiving the actual drug or the placebo. The study measures the safety and efficacy of azithromycin by monitoring the participants' health and symptoms throughout the trial. The potential benefits include a reduction in symptoms and improved health, while the risks are those typically associated with taking any new medication.

Principal SponsorPfizer
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.

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.

Over 18 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 DiseasesAnimal DiseasesCoccidiosisCommunicable DiseasesDigestive System DiseasesGastrointestinal DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsIntestinal DiseasesIntestinal Diseases, ParasiticParasitic DiseasesParasitic Diseases, AnimalProtozoan InfectionsProtozoan Infections, AnimalRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeCryptosporidiosisHIV Infections

Criteria

6 inclusion criteria required to participate
Allowed concurrent medication: Antidiarrheal medication with imodium or paregoric only

Allowed concurrent medication: Zidovudine

Allowed prior medication: Zidovudine

HIV infection

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9 exclusion criteria prevent from participating
Another investigational drug within 7 days prior to study enrollment (investigational medications available through a treatment IND will be allowed with the approval of the sponsor, the treatment IND sponsor, and the Pfizer clinical monitor)

Any drug or biologic preparation (e.g., bovine colostrum, paromomycin, spiramycin, somatostatin) with possible anticryptosporidial activity

Cancer chemotherapy (including therapy for Kaposi's sarcoma)

Causes for diarrhea other than, or in addition to, cryptosporidiosis

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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 4 locations

Infectious Disease Med Group

Oakland, United StatesOpen Infectious Disease Med Group in Google Maps

UCSD Med Ctr

San Diego, United States

Cornell Univ Med Ctr

New York, United States

Univ of Tennessee

Memphis, United States
Completed4 Study Centers