HIV InfectionsPhase 3NCT00002429
Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen
A Phase 3 study testing Lamivudine/Zidovudine, Nelfinavir mesylate and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 23 sites in 2 countries.
Trial summary
This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination. 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?
- Lamivudine/Zidovudine, Nelfinavir mesylate and Stavudine
- How many people
- 500 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Jul 1999to Jan 2001
- Phase
- Phase 3
- 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
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3.
- Are at least 18 years old.
- Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms).
Who cannot join
- Patients will not be eligible for this study if they:
- Have had severe diarrhea within 30 days of study entry.
- Have a history of pancreatic disease or any other serious condition.
- Have hepatitis within 30 days of study entry.
- Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment.
- Are unable to take medications by mouth.
- Have received certain medications.
- Are pregnant or breast-feeding.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States20 sites
Sorra Research Ctr / Med Forum
Birmingham, Alabama, 35203
The CORE Ctr
Chicago, Illinois, 60612
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Henry Ford Hosp
Detroit, Michigan, 48202
Med Alternatives
Fort Lauderdale, Florida, 33308
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Gathe, Joseph, M.D.
Houston, Texas, 77004
Montrose Clinic
Houston, Texas, 77006
Indiana Univ Med Ctr
Indianapolis, Indiana, 462025250
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, 03756
AIDS Healthcare Foundation
Los Angeles, California, 900276069
NJCRI
Newark, New Jersey, 07103
County Line Med CtrInc
Pembrook, Florida, 33023
Body Positive
Phoenix, Arizona, 85016
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213
San Francisco Gen Hosp
San Francisco, California, 94115
Infectious Disease Assoc of Central Jersey
Somerville, New Jersey, 08876
Dr Gerald Pierone Jr
Vero Beach, Florida, 32960
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124
Canada3 sites
Clinique Medicale du Quartier Latin
Montreal, Quebec
Clinique Medicale L'Actuele
Montreal, Quebec
Dr Roger P Leblanc
Montreal, Quebec
About this study
Official title: Evaluation of HIV RNA Suppression Produced by a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine (ddI EC) Administered Once Daily Compared to a Reference Combination Regimen
This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.
Read the detailed description
Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48.
- Conditions
- HIV Infections
- Being tested
- Lamivudine/Zidovudine, Nelfinavir mesylate, Stavudine, Didanosine
- Keywords
- Didanosine, Drug Therapy, Combination, Stavudine, RNA, Viral, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine/ZidovudineDrug
Nelfinavir mesylateDrug
StavudineDrug
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 startJul 1999
- Primary completionJan 2001
- Study completionJan 2001
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 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 3
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002429
- Sponsor's protocol ID
- 039F
- Other IDs
- AI454-152
- Status last verified
- Apr 2011
- First submitted
- 2 Nov 1999
- Last updated
- 4 May 2011
- Results posted
- No
Publications
Gathe J, Badero R, Grimwood A, Abrams L, Klesczewski K, Mclaren C. AI454152: Comparison of a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine Administered Once-Daily Versus a Regimen of Combivir Plus Nelfinavir. 8th Conference on Retroviruses and Opportunistic Infections, 2001 Feb 4-8. (abstract no 319)
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of HIV RNA Suppression Produced by a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine (ddI EC) Administered Once Daily Compared to a Reference Combination Regimen
- ClinicalTrials.gov ID
- NCT00002429
- Acronym / sponsor ID
- 039F
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drug Therapy, Combination, Stavudine, RNA, Viral, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 1999
- Primary completion
- Jan 2001 (actual)
- Study completion
- Jan 2001 (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.
This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.
Detailed description
Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are HIV-positive.
- Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3.
- Are at least 18 years old.
- Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms).
Key exclusion criteria (8 listed)
- Have had severe diarrhea within 30 days of study entry.
- Have a history of pancreatic disease or any other serious condition.
- Have hepatitis within 30 days of study entry.
- Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment.
- Are unable to take medications by mouth.
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 |
|---|---|---|
| Lamivudine/Zidovudine | Drug | – |
| Nelfinavir mesylate | Drug | – |
| Stavudine | 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 4 May 2011.
- BackgroundGathe J, Badero R, Grimwood A, Abrams L, Klesczewski K, Mclaren C. AI454152: Comparison of a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine Administered Once-Daily Versus a Regimen of Combivir Plus Nelfinavir. 8th Conference on Retroviruses and Opportunistic Infections, 2001 Feb 4-8. (abstract no 319)
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lamivudine/Zidovudine, Nelfinavir mesylate and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 23 sites in 2 countries.
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 8 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 4 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
On the ClinicalTrials.gov record for NCT00002429, 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 4 May 2011.