HIV InfectionsNCT00002411
A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs
A study testing Nelfinavir mesylate, Lamivudine and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 32 sites in United States.
Trial summary
The purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines how long these drug combinations are effective in lowering viral load (level of HIV in the blood). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nelfinavir mesylate, Lamivudine and Stavudine
- How many people
- Not given
- Where
- 32 sitesUnited States
- Study dates
- Mar 1998to Sep 1999
- 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:
- Within 15 business days prior to randomization:
- CD4 cell count greater than or equal to 100 cells/mm3.
- HIV RNA greater than or equal to 2,000 copies/ml by Roche Amplicor Assay.
Who cannot join
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Bilateral peripheral neuropathy.
- Intractable diarrhea.
- Proven or suspected acute hepatitis within 30 days prior to study entry.
- Concurrent Medication:
Show all 27Show fewer
- Excluded:
- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
- Concurrent Treatment:
- Excluded:
- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
- Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis.
- Prior Medication:
- Excluded:
- Therapy for any previous disease that may interfere with patient ability to participate in this study.
- Excluded within 14 days prior to randomization:
- Greater than 4 weeks of nucleoside therapy or greater than 1 week of protease inhibitor therapy.
- Excluded within 3 months of the start of this study or expected need at time of enrollment:
- Agents with significant systemic myelosuppressive, neurotoxic, pancreatoxic, hepatotoxic, or cytotoxic potential.
- Inability to tolerate oral medication.
- Prior Treatment:
- Excluded:
- Therapy for any previous disease that may interfere with patient ability to participate in this study.
- Risk Behavior:
- Excluded:
- Active alcohol or substance abuse that, in the opinion of the investigator, is sufficient to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Sorra Research Ctr / Med Forum
Birmingham, Alabama, 35203
Med Univ of South Carolina / Div of Infect Disease
Charleston, South Carolina, 29425
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207
Northwestern Univ / Div of Infect Diseases
Chicago, Illinois, 60611
Rush Presbyterian / ST Lukes Med Ctr
Chicago, Illinois, 60612
UCT International
Farmingdale, New York, 11735
Med Alternatives
Fort Lauderdale, Florida, 33308
Urgent Care Ctr
Fort Lauderdale, Florida, 33316
Hill Top Research Inc
Fresno, California, 93710
Univ of Texas / Med Branch at Galveston
Galveston, Texas, 775550835
Joseph C Gathe
Houston, Texas, 77004
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, 03756
Ky Clinic Annex #4 / Room 205E / Speed Sort #0284
Lexington, Kentucky, 405360226
UCLA Med Ctr / CARE BH-412 CHS
Los Angeles, California, 90024
AIDS Healthcare Foundation
Los Angeles, California, 900276069
West Los Angeles VAMC
Los Angeles, California, 90073
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142
Yale New Haven Hosp / Nathan Smith Clinic
New Haven, Connecticut, 06504
St Luke Roosevelt Hosp
New York, New York, 10011
NJCRI
Newark, New Jersey, 07103
Stephen P Hauptman
Philadelphia, Pennsylvania, 19107
Body Positive
Phoenix, Arizona, 85016
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642
Sherman Oaks Hosp Research Institute
Sherman Oaks, California, 91403
Infectious Disease Assoc of Central Jersey
Somerville, New Jersey, 08876
SUNY at Stony Brook / Div of Infectious Disease
Stony Brook, New York, 117948153
Hillsborough County Health Dept
Tampa, Florida, 33602
Saint Josephs Hosp
Tampa, Florida, 33602
Harbor UCLA Med Ctr / Research and Educational Institute
Torrance, California, 90502
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
GW Med Ctr / Clinical Trials Unit
Washington D.C., District of Columbia, 20037
Univ of Kansas School of Medicine / Office of Rsch
Wichita, Kansas, 67214
About this study
Official title: A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects
The purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines how long these drug combinations are effective in lowering viral load (level of HIV in the blood).
- Conditions
- HIV Infections
- Being tested
- Nelfinavir mesylate, Lamivudine, Stavudine, Zidovudine, Didanosine
- Keywords
- HIV-1, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, Lamivudine, RNA, Viral, Nelfinavir, 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.
Nelfinavir mesylateDrug
LamivudineDrug
StavudineDrug
ZidovudineDrug
DidanosineDrug
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 startMar 1998
- Primary completionSep 1999
- Study completionSep 1999
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 Bristol-Myers SquibbThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002411
- Sponsor's protocol ID
- 039E
- Other IDs
- AI454-148
- Status last verified
- Apr 2011
- First submitted
- 2 Nov 1999
- Last updated
- 25 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects
- ClinicalTrials.gov ID
- NCT00002411
- Acronym / sponsor ID
- 039E
- Conditions
- HIV Infections
- Keywords
- HIV-1, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, Lamivudine, RNA, Viral, Nelfinavir
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 1998
- Primary completion
- Sep 1999 (actual)
- Study completion
- Sep 1999 (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.
The purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines how long these drug combinations are effective in lowering viral load (level of HIV in the blood).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- CD4 cell count greater than or equal to 100 cells/mm3.
- HIV RNA greater than or equal to 2,000 copies/ml by Roche Amplicor Assay.
Key exclusion criteria (27 listed)
- Bilateral peripheral neuropathy.
- Intractable diarrhea.
- Proven or suspected acute hepatitis within 30 days prior to study entry.
- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
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 | – |
| Lamivudine | Drug | – |
| Stavudine | Drug | – |
| Zidovudine | Drug | – |
| Didanosine | 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 25 Apr 2011.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nelfinavir mesylate, Lamivudine and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 32 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 4 inclusion and 27 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 25 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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 25 Apr 2011.