Protozoan InfectionsPhase 3NCT00002191
A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis
A Phase 3 study testing Albendazole in people with Protozoan Infections and HIV Infections, run by SmithKline Beecham at 6 sites in United States.
Trial summary
To evaluate the efficacy (stool frequency) and safety (adverse experiences) of albendazole, administered for 28 days, compared to placebo and for 62 days in open-label fashion, in treating intestinal microsporidiosis in HIV-positive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Protozoan Infections, HIV Infections
- What is being tested?
- Albendazole
- How many people
- Not given
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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:
- Required:
- If coincident enteric pathogens that are not eradicable (i.e., Mycobacterium avium complex) are detected, they should be treated appropriately and the patient must be on a stable regimen of therapy for at least two weeks.
- Allowed:
- Patients taking antidiarrheal medications must be on a stable regimen for at least seven days prior to randomization.
- Patients taking other concomitant medications, including antiretrovirals, must be on a stable regimen for two weeks prior to randomization.
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- Patients must have:
- HIV positive status. Written documentation (for example, patient's chart) of HIV diagnosis is acceptable in lieu of repeat testing. Confirmation by Western blot is not necessary.
- Biopsy-proven microsporidiosis of the fourth portion of the duodenum or proximal jejunum within 90 days before randomization.
- Average of > 3 liquid bowel movements per day over 7 consecutive days immediately prior to randomization, with an average volume > 500 ml per day over three or more consecutive days immediately prior to randomization, as documented by data collected in a daily diary. NOTE:
- Patients receiving antidiarrheal therapy must meet these criteria despite such therapy.
- History of an average of > 3 liquid bowel movements per day for three additional weeks immediately preceding the 7-day period described above (for a total of four weeks), as documented in the patient's chart.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Grade 4 neutropenia.
- Decompensated liver disease.
- Positive toxin analysis for C. difficile.
- Positive microscopic examination for Giardia lamblia, Entamoeba histolytica, and Isospora belli.
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- Positive on culture for Shigella, Salmonella, Yersinia and Campylobacter.
- Positive fluorescent antibody test for Cryptosporidium.
- Evidence of CMV on small bowel biopsy, flexible sigmoidoscopic or colonoscopic biopsies within 90 days of randomization.
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study entry.
- Patients with the following prior conditions are excluded:
- Hypersensitivity to albendazole.
- Prior Medication:
- Excluded:
- Use of potential antiprotozoal drugs, e.g., mebendazole or metronidazole, within one week prior to enrollment.
- Receipt of albendazole during the one month prior to enrollment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Deaconess Hosp / Harvard Med School / Infect Disease
Boston, Massachusetts, 02215
New York Univ
New York, New York, 10016
Saint Luke's Hosp / Services and Research 1301
New York, New York, 10025
San Francisco Gen Hosp / Div of GI
San Francisco, California, 94110
Davies Med Ctr
San Francisco, California, 94114
George Washington Univ 5-403A
Washington D.C., District of Columbia, 20037
About this study
To evaluate the efficacy (stool frequency) and safety (adverse experiences) of albendazole, administered for 28 days, compared to placebo and for 62 days in open-label fashion, in treating intestinal microsporidiosis in HIV-positive patients. To assess the effect of albendazole on stool volume, weight gain, microsporidial counts in small bowel biopsies, and on the relationship between microsporidial counts in stool and stool frequency and volume. To correlate microsporidial counts with the clinical course of microsporidiosis.
Read the detailed description
In the double-blind portion of study, patients receive albendazole or placebo for 28 days; in the open-label portion of study, patients receive albendazole for 62 days.
- Conditions
- Protozoan Infections, HIV Infections
- Being tested
- Albendazole
- Keywords
- AIDS-Related Opportunistic Infections, Placebos, Protozoan Infections, Intestinal Diseases, Albendazole, Microsporida, Anthelmintics
- Medical subject headings
- Protozoan Infections, HIV Infections, AIDS-Related Opportunistic Infections, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
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 Protozoan 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 3
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- SmithKline Beecham
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002191
- Sponsor's protocol ID
- 274A
- Other IDs
- SK 62979/029, GHBA 659
- Status last verified
- Jul 1997
- 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
- A Double-Blind, Placebo-Controlled Trial of Albendazole in HIV-Positive Patients With Intestinal Microsporidiosis
- ClinicalTrials.gov ID
- NCT00002191
- Acronym / sponsor ID
- 274A
- Conditions
- Protozoan Infections, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Placebos, Protozoan Infections, Intestinal Diseases, Albendazole, Microsporida, Anthelmintics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SmithKline BeechamIndustry (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 efficacy (stool frequency) and safety (adverse experiences) of albendazole, administered for 28 days, compared to placebo and for 62 days in open-label fashion, in treating intestinal microsporidiosis in HIV-positive patients. To assess the effect of albendazole on stool volume, weight gain, microsporidial counts in small bowel biopsies, and on the relationship between microsporidial counts in stool and stool frequency and volume. To correlate microsporidial counts with the clinical course of microsporidiosis.
Detailed description
In the double-blind portion of study, patients receive albendazole or placebo for 28 days; in the open-label portion of study, patients receive albendazole for 62 days.
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 (12 listed)
- If coincident enteric pathogens that are not eradicable (i.e., Mycobacterium avium complex) are detected, they should be treated appropriately and the patient must be on a stable regimen of therapy for at least two weeks.
- Patients taking antidiarrheal medications must be on a stable regimen for at least seven days prior to randomization.
- Patients taking other concomitant medications, including antiretrovirals, must be on a stable regimen for two weeks prior to randomization.
- HIV positive status. Written documentation (for example, patient's chart) of HIV diagnosis is acceptable in lieu of repeat testing. Confirmation by Western blot is not necessary.
- Biopsy-proven microsporidiosis of the fourth portion of the duodenum or proximal jejunum within 90 days before randomization.
Key exclusion criteria (16 listed)
- Grade 4 neutropenia.
- Decompensated liver disease.
- Positive toxin analysis for C. difficile.
- Positive microscopic examination for Giardia lamblia, Entamoeba histolytica, and Isospora belli.
- Positive on culture for Shigella, Salmonella, Yersinia and Campylobacter.
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 |
|---|---|---|
| Albendazole | 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albendazole in people with Protozoan Infections and HIV Infections, run by SmithKline Beecham at 6 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 12 inclusion and 16 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 6 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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.