Mycobacterium Avium-Intracellulare InfectionPhase 2NCT00002170
A Study of Viracept in AIDS Patients With Mycobacterium Avium Complex Disease (MAC)
A Phase 2 study testing Nelfinavir mesylate in people with Mycobacterium Avium-Intracellulare Infection and HIV Infections, run by Agouron Pharmaceuticals at 5 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are being treated for MAC. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Mycobacterium Avium-Intracellulare Infection, HIV Infections
- What is being tested?
- Nelfinavir mesylate
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- HIV infection
- New diagnosis of MAC bacteremia and < 7 days of therapy.
- Prior Medication:
- Allowed:
- Patients no more than 7 days of therapy for MAC disease.
Who cannot join
- Prior Medication:
- Excluded:
- Prior therapy (or less than 2 weeks) with protease inhibitors other than saquinavir.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Boston VA Med Ctr / 151
Boston, Massachusetts, 02730
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Baylor Univ
Houston, Texas, 77009
Univ of California / San Diego Treatment Ctr
San Diego, California, 92103
Harbor UCLA Med Ctr
Torrance, California, 90502
About this study
Official title: A Pilot, Phase II, Randomized, Placebo-Controlled Study to Determine the Effects of Viracept on the Clinical Outcome of Disseminated Mycobacterium Avium Complex Disease (MAC) in AIDS Patients Who Are Receiving Standard Acute Treatment for This Opportunistic Infection
The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are being treated for MAC.
- Being tested
- Nelfinavir mesylate
- Keywords
- AIDS-Related Opportunistic Infections, Placebos, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, Nelfinavir, Anti-Infective Agents, Anti-HIV Agents
- Medical subject headings
- Mycobacterium avium-intracellulare Infection, HIV Infections, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelfinavir mesylateDrug
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 Mycobacterium Avium-Intracellulare 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Agouron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002170
- Sponsor's protocol ID
- 259C
- Other IDs
- Study 518, AG1343-518
- Status last verified
- May 1999
- 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 Pilot, Phase II, Randomized, Placebo-Controlled Study to Determine the Effects of Viracept on the Clinical Outcome of Disseminated Mycobacterium Avium Complex Disease (MAC) in AIDS Patients Who Are Receiving Standard Acute Treatment for This Opportunistic Infection
- ClinicalTrials.gov ID
- NCT00002170
- Acronym / sponsor ID
- 259C
- Keywords
- AIDS-Related Opportunistic Infections, Placebos, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, Nelfinavir, Anti-Infective Agents, Anti-HIV Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Agouron PharmaceuticalsIndustry (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.
The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are being treated for MAC.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- HIV infection
- New diagnosis of MAC bacteremia and < 7 days of therapy.
- Patients no more than 7 days of therapy for MAC disease.
Key exclusion criteria (3 listed)
- Prior therapy (or less than 2 weeks) with protease inhibitors other than saquinavir.
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 |
|---|---|---|
| Nelfinavir mesylate | 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nelfinavir mesylate in people with Mycobacterium Avium-Intracellulare Infection and HIV Infections, run by Agouron Pharmaceuticals at 5 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 6 inclusion and 3 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 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.