Mycobacterium Avium-intracellular InfectionNCT00002336
The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients
A study testing Clarithromycin in people with Mycobacterium Avium-intracellular Infection and HIV Infections, run by Abbott at 22 sites in United States.
Trial summary
To determine whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts <= 100 cells/mm3. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Mycobacterium Avium-intracellular Infection, HIV Infections
- What is being tested?
- Clarithromycin
- How many people
- Not given
- Where
- 22 sitesUnited States
- Study dates
- Nov 1992to Nov 1994
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- HIV infection.
- CD4 count <= 100 cells/mm3.
- No evidence of MAC.
- Life expectancy of at least 6 months.
Who cannot join
- Concurrent Medication:
- Excluded:
- Certain restricted drugs (details not available).
- Patients with the following prior conditions are excluded:
- History of allergy or hypersensitivity to macrolides. Active substance abuse or other conditions that would affect study compliance.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Nalle Clinic
Charlotte, North Carolina, 28207
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308
California Med Research Group
Fresno, California, 93726
Dr Nelson Zide
Hollywood, Florida, 33021
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
Indiana Univ Hosp
Indianapolis, Indiana, 46202
Univ of Tennessee
Memphis, Tennessee, 38163
Vanderbilt Univ
Nashville, Tennessee, 37212
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011
Westover Heights Clinic
Portland, Oregon, 97210
Salem Veterans Administration Med Ctr
Salem, Virginia, 24153
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
HIV Research Group
San Diego, California, 92102
Saint Francis Mem Hosp
San Francisco, California, 94109
Kaiser Permanente Med Ctr
San Francisco, California, 94115
Santa Clara Valley Med Ctr
San Jose, California, 951282699
SUNY / Health Sciences Ctr at Syracuse
Syracuse, New York, 13210
Dr Alan D Tice / Infections Ltd
Tacoma, Washington, 98405
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
New York Med College / Westchester County Med Ctr
Valhalla, New York, 10595
About this study
Official title: A Prospective, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Clarithromycin for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients With CD4 Counts <= 100 Cells/mm3
To determine whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts <= 100 cells/mm3.
- Being tested
- Clarithromycin
- Keywords
- Mycobacterium avium-intracellular Infection, Acquired Immunodeficiency Syndrome, Clarithromycin
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
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 startNov 1992
- Primary completionNov 1994
- Study completionNov 1994
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 Mycobacterium Avium-intracellular InfectionStudies 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 N/A
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002336
- Sponsor's protocol ID
- 124A
- Other IDs
- M91-561
- Status last verified
- Feb 2009
- First submitted
- 2 Nov 1999
- Last updated
- 16 Jan 2015
- Results posted
- No
Publications
Pierce M, Crampton S, Henry D, Heifets L, LaMarca A, Montecalvo M, Wormser GP, Jablonowski H, Jemsek J, Cynamon M, Yangco BG, Notario G, Craft JC. A randomized trial of clarithromycin as prophylaxis against disseminated Mycobacterium avium complex infection in patients with advanced acquired immunodeficiency syndrome. N Engl J Med. 1996 Aug 8;335(6):384-91. doi: 10.1056/NEJM199608083350603.
PubMed 8663871
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Clarithromycin for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients With CD4 Counts <= 100 Cells/mm3
- ClinicalTrials.gov ID
- NCT00002336
- Acronym / sponsor ID
- 124A
- Keywords
- Mycobacterium avium-intracellular Infection, Acquired Immunodeficiency Syndrome, Clarithromycin
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 1992
- Primary completion
- Nov 1994 (actual)
- Study completion
- Nov 1994 (actual)
- 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 whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts <= 100 cells/mm3.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- HIV infection.
- CD4 count <= 100 cells/mm3.
- No evidence of MAC.
- Life expectancy of at least 6 months.
Key exclusion criteria (5 listed)
- Certain restricted drugs (details not available).
- History of allergy or hypersensitivity to macrolides. Active substance abuse or other conditions that would affect study compliance.
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 |
|---|---|---|
| Clarithromycin | 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 16 Jan 2015.
- Background: PubMed 8663871Pierce M, Crampton S, Henry D, Heifets L, LaMarca A, Montecalvo M, Wormser GP, Jablonowski H, Jemsek J, Cynamon M, Yangco BG, Notario G, Craft JC. A randomized trial of clarithromycin as prophylaxis against disseminated Mycobacterium avium complex infection in patients with advanced acquired immunodeficiency syndrome. N Engl J Med. 1996 Aug 8;335(6):384-91. doi: 10.1056/NEJM199608083350603.
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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clarithromycin in people with Mycobacterium Avium-intracellular Infection and HIV Infections, run by Abbott at 22 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 5 inclusion and 5 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 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
On the ClinicalTrials.gov record for NCT00002336, 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 16 Jan 2015.