HIV InfectionsPhase 1NCT00002444
A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea
A Phase 1 study testing Nitazoxanide in people with HIV Infections, run by Unimed Pharmaceuticals at 1 site in United States.
Trial summary
To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nitazoxanide
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1995to Feb 1996
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- AIDS diagnosis according to CDC criteria.
- CD4 count less than or equal to 200 cells/mm3 or CD4 count greater than or equal to 200 cells/mm3 and documented cryptosporidiosis for a minimum of 4 weeks.
- Cryptosporidial diarrhea as defined by:
- (1) presence of Cryptosporidium oocytes in a stool specimen within 14 days of enrollment; and (2) chronic diarrhea (i.e., an average of at least 4 bowel movements per day for a minimum of 2 weeks).
- Life expectancy of at least 1 month.
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- Ability to tolerate food by mouth.
- Prior Medication:
- Required:
- Any anti-diarrheal or anti-emetic medication for which the dosage regimen has been stable for at least 1 week prior to enrollment.
- Any antiretroviral medications (e.g., zidovudine, ddI, ddC) for which the dosage regimen has been stable for at least 3 weeks prior to enrollment.
- Allowed:
- Medication for prophylaxis or maintenance therapy of opportunistic infection, stable for at least 2 weeks prior to enrollment.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Grade 4 (hematologic) or Grade 3 (for all others) toxicity. (Patients with Grade 3 toxicity for hepatic parameters may be enrolled if, in the investigator's judgment, the abnormalities are due to biliary cryptosporidiosis.)
- Patients with the following prior conditions are excluded:
- Presence of Salmonella, Shigella, Campylobacter, Yersinia, Giardia lamblia, Entamoeba histolytica, Microsporidia, Isospora, Cyclospora, or Clostridium difficile toxin in stool (based on assessment within 14 days prior to enrollment by stool ova and parasite examination, culture, and C. difficile assay).
- History of intestinal Mycobacterium avium intracellular infection or intestinal Kaposi's sarcoma.
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- History of Cytomegalovirus colitis, unless 28 days of therapy with ganciclovir or foscarnet completed subsequent to diagnosis.
- Prior Medication:
- Excluded:
- Investigational drug therapy within 14 days of enrollment, unless available under an FDA-authorized expanded access program.
- Any drug or therapy with possible anticryptosporidial activity (e.g., paromomycin, spiramycin, azithromycin, clarithromycin, hyperimmune bovine colostrum) within 14 days of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Hosp / Cornell Med Ctr
New York, New York, 10021
About this study
Official title: Phase I/II Open Label Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in these patients.
Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection.
Read the detailed description
Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection.
Patients are enrolled in groups of 7. Group A receives the lowest dose of NTZ. Groups B - D receive sequentially higher doses. Patients in Groups B - D do not begin therapy until all patients have been enrolled at the preceding dose. For determination of single-dose pharmacokinetics, patients receive a single dose of NTZ on Day 1 and blood samples are obtained over the next 24 hours. Immediately following the 24-hour blood sample collection, patients begin the treatment phase during which they take NTZ for an additional 13 days. Blood samples are obtained again on Day 14 to determine full plasma concentration-time profiles over the dosing interval. At the end of treatment, responders discontinue treatment and nonresponders continue NTZ treatment for an additional 14 days on the same dose. Patients who still fail to respond are provided with an additional month of NTZ. Patients have scheduled visits for clinical and parasitologic efficacy assessments and safety laboratory tests.
- Conditions
- HIV Infections
- Being tested
- Nitazoxanide
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startOct 1995
- Study completionFeb 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 28 participants
Sponsor and investigators
- Lead sponsor
- Unimed Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rosemary Soave, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002444
- Sponsor's protocol ID
- 253A
- Other IDs
- UMD-95-004
- Status last verified
- Feb 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Mazzoni S, Hill P, Briggs A, Barbier K, Cahill A, Macones G, Colditz G, Tuuli M, Carter E. The effect of group prenatal care for women with diabetes on social support and depressive symptoms: a pilot randomized trial. J Matern Fetal Neonatal Med. 2020 May;33(9):1505-1510. doi: 10.1080/14767058.2018.1520832. Epub 2018 Sep 25.
PubMed 30251569
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Open Label Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
- ClinicalTrials.gov ID
- NCT00002444
- Acronym / sponsor ID
- 253A
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants
- Lead sponsor
- Unimed PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 1995
- Study completion
- Feb 1996
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in these patients.
Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection.
Detailed description
Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection.
Patients are enrolled in groups of 7. Group A receives the lowest dose of NTZ. Groups B - D receive sequentially higher doses. Patients in Groups B - D do not begin therapy until all patients have been enrolled at the preceding dose. For determination of single-dose pharmacokinetics, patients receive a single dose of NTZ on Day 1 and blood samples are obtained over the next 24 hours. Immediately following the 24-hour blood sample collection, patients begin the treatment phase during which they take NTZ for an additional 13 days. Blood samples are obtained again on Day 14 to determine full plasma concentration-time profiles over the dosing interval. At the end of treatment, responders discontinue treatment and nonresponders continue NTZ treatment for an additional 14 days on the same dose. Patients who still fail to respond are provided with an additional month of NTZ. Patients have scheduled visits for clinical and parasitologic efficacy assessments and safety laboratory tests.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- AIDS diagnosis according to CDC criteria.
- CD4 count less than or equal to 200 cells/mm3 or CD4 count greater than or equal to 200 cells/mm3 and documented cryptosporidiosis for a minimum of 4 weeks.
- Cryptosporidial diarrhea as defined by:
- (1) presence of Cryptosporidium oocytes in a stool specimen within 14 days of enrollment; and (2) chronic diarrhea (i.e., an average of at least 4 bowel movements per day for a minimum of 2 weeks).
- Life expectancy of at least 1 month.
Key exclusion criteria (11 listed)
- Grade 4 (hematologic) or Grade 3 (for all others) toxicity. (Patients with Grade 3 toxicity for hepatic parameters may be enrolled if, in the investigator's judgment, the abnormalities are due to biliary cryptosporidiosis.)
- Presence of Salmonella, Shigella, Campylobacter, Yersinia, Giardia lamblia, Entamoeba histolytica, Microsporidia, Isospora, Cyclospora, or Clostridium difficile toxin in stool (based on assessment within 14 days prior to enrollment by stool ova and parasite examination, culture, and C. difficile assay).
- History of intestinal Mycobacterium avium intracellular infection or intestinal Kaposi's sarcoma.
- History of Cytomegalovirus colitis, unless 28 days of therapy with ganciclovir or foscarnet completed subsequent to diagnosis.
- Investigational drug therapy within 14 days of enrollment, unless available under an FDA-authorized expanded access program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitazoxanide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Derived from this study: PubMed 30251569Mazzoni S, Hill P, Briggs A, Barbier K, Cahill A, Macones G, Colditz G, Tuuli M, Carter E. The effect of group prenatal care for women with diabetes on social support and depressive symptoms: a pilot randomized trial. J Matern Fetal Neonatal Med. 2020 May;33(9):1505-1510. doi: 10.1080/14767058.2018.1520832. Epub 2018 Sep 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosemary Soave principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nitazoxanide in people with HIV Infections, run by Unimed Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.