Suspended

Nitazoxanide Therapy for Cryptosporidiosis in AIDS Patients

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What is being tested

Nitazoxanide

Drug
Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2000
See protocol details

Summary

Principal SponsorRomark Laboratories L.C.
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2000

Actual date on which the first participant was enrolled.

Patients take nitazoxanide daily for 8 weeks with a dose escalation after the first 4 weeks. Patients return to the hospital for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up. Nitazoxanide therapy is discontinued in patients showing a complete clinical and parasitologic response (therapeutic cure) after 8 weeks of treatment and in patients showing a therapeutic cure at two consecutive visits (Weeks 2 and 4 or Weeks 4 and 6). These patients undergo a physical examination including stool analysis for Cryptosporidium parvum oocysts and routine laboratory tests at Weeks 2, 4, and 6 after completion of nitazoxanide therapy. Patients who do not show a complete clinical and parasitologic response (therapeutic failure) after 8 weeks of treatment are allowed to remain on nitazoxanide therapy through the Open Label Compassionate Use of Nitazoxanide in Treatment of Cryptosporidiosis in AIDS Patients (UMD-95-009) protocol.

NCT00004986
Principal SponsorRomark Laboratories L.C.
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

30 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.

Over 13 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, ParasiticOpportunistic InfectionsParasitic DiseasesParasitic Diseases, AnimalProtozoan InfectionsProtozoan Infections, AnimalRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsCryptosporidiosisHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

7 inclusion criteria required to participate
Agree to use an effective method of birth control (such as condoms) during the study
Are HIV-positive
Are able to take medications by mouth
Are at least 13 years old (consent of parent or guardian required if under 18)
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6 exclusion criteria prevent from participating
Are pregnant or breast-feeding
Have certain diseases or infections of the intestines
Have ever taken nitazoxanide
Have started a new anti-HIV therapy within 4 weeks of study entry or plan on starting one during the study
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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 1 location

Julie Ryner

Tampa, United StatesOpen Julie Ryner in Google Maps
SuspendedOne Study Center