CryptosporidiosisNCT00002082
Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
A study testing Azithromycin in people with Cryptosporidiosis and HIV Infections, run by Pfizer at 4 sites in United States.
Trial summary
To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptosporidiosis, HIV Infections
- What is being tested?
- Azithromycin
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Zidovudine.
- Antidiarrheal medication with imodium or paregoric only.
- Patients must have:
- HIV infection.
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- Intestinal cryptosporidiosis proven by stool microscopy on at least two occasions prior to study enrollment.
- Life expectancy of at least 2 weeks by clinical assessment. In states where the legal age of consent for medical procedures is 21 years, patients below the age of 21 must have consent of parent or guardian.
- Prior Medication:
- Allowed:
- Zidovudine.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Known hypersensitivity or significant intolerance to macrolide antibiotics.
- Marked abnormalities of liver or renal function.
- Causes for diarrhea other than, or in addition to, cryptosporidiosis.
- Inability to receive oral medication.
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- Concurrent Medication:
- Excluded:
- Cancer chemotherapy (including therapy for Kaposi's sarcoma).
- Any drug or biologic preparation (e.g., bovine colostrum, paromomycin, spiramycin, somatostatin) with possible anticryptosporidial activity.
- Immunostimulant or lymphocyte replacement therapy.
- Prior Medication:
- Excluded:
- 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).
- Immunostimulant or lymphocyte replacement therapy.
- Cancer chemotherapy (including therapy for Kaposi's sarcoma).
- Not expected to comply with the requirements of the protocol, in the opinion of the investigator.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Univ of Tennessee
Memphis, Tennessee, 38103
Cornell Univ Med Ctr
New York, New York, 10021
Infectious Disease Med Group
Oakland, California, 94609
UCSD Med Ctr
San Diego, California, 92103
About this study
To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.
- Conditions
- Cryptosporidiosis, HIV Infections
- Being tested
- Azithromycin
- Keywords
- Cryptosporidiosis, Acquired Immunodeficiency Syndrome, Azithromycin
- Medical subject headings
- Cryptosporidiosis, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryptosporidiosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002082
- Sponsor's protocol ID
- 058F
- Other IDs
- 066-143
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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
- Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
- ClinicalTrials.gov ID
- NCT00002082
- Acronym / sponsor ID
- 058F
- Conditions
- Cryptosporidiosis, HIV Infections
- Keywords
- Cryptosporidiosis, Acquired Immunodeficiency Syndrome, Azithromycin
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- 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 evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Zidovudine.
- Antidiarrheal medication with imodium or paregoric only.
- HIV infection.
- Intestinal cryptosporidiosis proven by stool microscopy on at least two occasions prior to study enrollment.
- Life expectancy of at least 2 weeks by clinical assessment. In states where the legal age of consent for medical procedures is 21 years, patients below the age of 21 must have consent of parent or guardian.
Key exclusion criteria (17 listed)
- Known hypersensitivity or significant intolerance to macrolide antibiotics.
- Marked abnormalities of liver or renal function.
- Causes for diarrhea other than, or in addition to, cryptosporidiosis.
- Inability to receive oral medication.
- Cancer chemotherapy (including therapy for Kaposi's sarcoma).
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 |
|---|---|---|
| Azithromycin | 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azithromycin in people with Cryptosporidiosis and HIV Infections, run by Pfizer at 4 sites 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 11 inclusion and 17 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 4 sites 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.
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?
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.