HIV InfectionsPhase 2NCT00002452
A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir
A Phase 2 study testing L-756423 and Indinavir sulfate in people with HIV Infections, run by Merck Sharp & Dohme LLC at 8 sites in United States.
Trial summary
The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with indinavir and if it works well at lowering the level of HIV in the blood (viral load). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- L-756423 and Indinavir sulfate
- How many people
- 30 participants
- Where
- 8 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are HIV-positive.
- Are at least 18 years old.
- Have a viral load of at least 1,000 copies/ml.
- Have a CD4 cell count of at least 100 cells/mm3.
- Have experienced treatment failure (your viral load increased significantly) within 24 weeks of study entry while taking indinavir.
Who cannot join
- You will not be eligible for this study if you:
- Are taking nonnucleoside reverse transcriptase inhibitors (NNRTIs).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942050
The CORE Ctr
Chicago, Illinois, 60612
Hawaii AIDS Clinical Trial Unit
Honolulu, Hawaii, 96816
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, 10011
Pittsburgh Treatment Ctr / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Georgetown Univ
Washington D.C., District of Columbia, 20007
About this study
Official title: A Multicenter, Open-Label, Pilot Study to Evaluate the Safety and Activity of L-756423/Indinavir Sulfate, 800/400 Mg b.i.d. in Combination With Two nRTIs in HIV-Infected Patients Who Failed an Indinavir Containing Regimen
The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with indinavir and if it works well at lowering the level of HIV in the blood (viral load).
Read the detailed description
All patients receive L-756423 plus indinavir plus two licensed nucleoside reverse transcriptase inhibitors (NRTIs), at least one to which the patient is naive. Patients remain on the drug regimen for 12 weeks (with possible extension to 16 weeks). Patients are evaluated with physical examinations and laboratory tests for blood and urine at Weeks 1, 2, 4, 6, 8, and 12 and two weeks post study. Plasma viral RNA is measured at Weeks 1, 2, 4, 6, 8, and 12. CD4 cell counts are measured at Weeks 2,4,8, and 12.
- Conditions
- HIV Infections
- Being tested
- L-756423, Indinavir sulfate
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-756423Drug
Indinavir sulfateDrug
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 HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 2
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002452
- Sponsor's protocol ID
- 300A
- Other IDs
- 008-00
- Status last verified
- Feb 2000
- First submitted
- 17 Jan 2000
- 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 Multicenter, Open-Label, Pilot Study to Evaluate the Safety and Activity of L-756423/Indinavir Sulfate, 800/400 Mg b.i.d. in Combination With Two nRTIs in HIV-Infected Patients Who Failed an Indinavir Containing Regimen
- ClinicalTrials.gov ID
- NCT00002452
- Acronym / sponsor ID
- 300A
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (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 L-756423, an anti-HIV drug, is safe to give with indinavir and if it works well at lowering the level of HIV in the blood (viral load).
Detailed description
All patients receive L-756423 plus indinavir plus two licensed nucleoside reverse transcriptase inhibitors (NRTIs), at least one to which the patient is naive. Patients remain on the drug regimen for 12 weeks (with possible extension to 16 weeks). Patients are evaluated with physical examinations and laboratory tests for blood and urine at Weeks 1, 2, 4, 6, 8, and 12 and two weeks post study. Plasma viral RNA is measured at Weeks 1, 2, 4, 6, 8, and 12. CD4 cell counts are measured at Weeks 2,4,8, and 12.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are HIV-positive.
- Are at least 18 years old.
- Have a viral load of at least 1,000 copies/ml.
- Have a CD4 cell count of at least 100 cells/mm3.
- Have experienced treatment failure (your viral load increased significantly) within 24 weeks of study entry while taking indinavir.
Key exclusion criteria (2 listed)
- Are taking nonnucleoside reverse transcriptase inhibitors (NNRTIs).
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 |
|---|---|---|
| L-756423 | Drug | – |
| Indinavir sulfate | 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.
8 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 L-756423 and Indinavir sulfate in people with HIV Infections, run by Merck Sharp & Dohme LLC at 8 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 2 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 8 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.