HIV InfectionsNCT00002430
A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
A study testing Indinavir sulfate, Nelfinavir mesylate and Lamivudine in people with HIV Infections, run by Merck Sharp & Dohme LLC at 46 sites in United States.
Trial summary
The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Indinavir sulfate, Nelfinavir mesylate and Lamivudine
- How many people
- 220 participants
- Where
- 46 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are HIV positive.
- Have a viral load (level of HIV in your blood) of at least 10,000 copies/ml within 45 days of study entry.
- Have a CD4 cell count of at least 100 cells/mm3 within 45 days of study entry.
- Have a normal chest X-ray.
- Have never taken protease inhibitors or 3TC.
- Are 16 years of age or older.
- Agree to practice sexual abstinence or use barrier methods of birth control (e.g., condoms).
Who cannot join
- You will not be eligible for this study if you:
- Have an active opportunistic (AIDS-related) infection or cancer.
- Have certain types of Kaposi's sarcoma.
- Have hepatitis.
- Have chronic diarrhea.
- Have a history of certain medical conditions.
Show all 9Show fewer
- Are allergic to any of the study medications.
- Are taking certain medications.
- Are pregnant or breast-feeding.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
IDC Research Initiative
Altamonte Springs, Florida, 32701
Emory Univ
Atlanta, Georgia, 30308
Institute of Human Virology
Baltimore, Maryland, 21201
Thomas Coffman MD
Boise, Idaho, 83712
JSI Research and Training Institute
Boston, Massachusetts, 02210
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, 112123198
Education & Research Building
Camden, New Jersey, 08103
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
Northwestern Univ Med Ctr
Chicago, Illinois, 60611
Univ of Illinois
Chicago, Illinois, 60612
Burnside Clinic
Columbia, South Carolina, 29206
Oak Lawn Physicians Group
Dallas, Texas, 75219
Denver Public Health Dept
Denver, Colorado, 80204
Univ TX Galveston Med Branch
Galveston, Texas, 77555
Kentucky Clinical Research
Lexington, Kentucky, 40504
Ocean View Internal Medicine
Long Beach, California, 90803
AIDS Healthcare Foundation
Los Angeles, California, 90027
Tower ID Med Associates
Los Angeles, California, 90048
Oasis Clinic / King Drew Med Ctr
Los Angeles, California, 90059
Harold Katner MD
Macon, Georgia, 31202
Univ of Miami School of Medicine
Miami, Florida, 33136
Univ of Alabama School of Med
Montgomery, Alabama, 36116
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
Liberty Med Group
New York, New York, 10016
James Jones MD
New York, New York, 10019
Mount Sinai Med Ctr
New York, New York, 10029
NJCRI
Newark, New Jersey, 07103
Robert Scott MD
Oakland, California, 94609
Anderson Clinical Research / Inc
Pittsburgh, Pennsylvania, 15213
AIDS Consultation Service / Maine Med Ctr
Portland, Maine, 04102
The Research and Education Group
Portland, Oregon, 97210
Fanno Creek Clinic
Portland, Oregon, 97219
AIDS Community Research Consortium
Redwood City, California, 94063
Community Health Network
Rochester, New York, 14620
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, 94109
Pacific Horizons Med Group
San Francisco, California, 94115
Kaiser Foundation Hospital
San Francisco, California, 94118
Blick Med Associates
Stamford, Connecticut, 06901
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, 98405
Hillsborough County Health Dept
Tampa, Florida, 33602
Harbor - UCLA Med Ctr
Torrance, California, 90502
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
Infectious Disease Specialists of NJ
Union, New Jersey, 07083
Physicans Home Service
Washington D.C., District of Columbia, 20037
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals
The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.
Read the detailed description
Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Nelfinavir mesylate, Lamivudine, Stavudine
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indinavir sulfateDrug
Nelfinavir mesylateDrug
LamivudineDrug
StavudineDrug
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 N/A
- Primary purpose
- Treatment
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002430
- Sponsor's protocol ID
- 246R
- Other IDs
- 079-02, CRX454
- Status last verified
- Feb 2000
- 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 Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals
- ClinicalTrials.gov ID
- NCT00002430
- Acronym / sponsor ID
- 246R
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 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 compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.
Detailed description
Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Are HIV positive.
- Have a viral load (level of HIV in your blood) of at least 10,000 copies/ml within 45 days of study entry.
- Have a CD4 cell count of at least 100 cells/mm3 within 45 days of study entry.
- Have a normal chest X-ray.
- Have never taken protease inhibitors or 3TC.
Key exclusion criteria (9 listed)
- Have an active opportunistic (AIDS-related) infection or cancer.
- Have certain types of Kaposi's sarcoma.
- Have hepatitis.
- Have chronic diarrhea.
- Have a history of certain medical conditions.
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 |
|---|---|---|
| Indinavir sulfate | Drug | – |
| Nelfinavir mesylate | Drug | – |
| Lamivudine | Drug | – |
| Stavudine | 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.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indinavir sulfate, Nelfinavir mesylate and Lamivudine in people with HIV Infections, run by Merck Sharp & Dohme LLC at 46 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 8 inclusion and 9 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 46 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.