HIV InfectionsPhase 3NCT00002224
Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)
A Phase 3 study testing Nelfinavir mesylate, Stavudine and Didanosine in people with HIV Infections, run by Bristol-Myers Squibb at 24 sites in 2 countries.
Trial summary
Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. 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?
- Nelfinavir mesylate, Stavudine and Didanosine
- How many people
- 120 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Mar 1999to Mar 1999
- 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
- 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 5,000 copies/ml and a CD4 count of at least 100 cells/mm3.
Who cannot join
- You will not be eligible for this study if you:
- Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.)
- Have severe diarrhea.
- Are pregnant or breast-feeding.
- Have a history of pancreatic disease or any other serious condition.
- Have hepatitis within 30 days prior to study entry.
- Cannot take medications by mouth.
- Have received certain medications.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States22 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 303081962
Sorra Research Ctr / Med Forum
Birmingham, Alabama, 35203
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, 80304
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
Oak Lawn Physicians Group
Dallas, Texas, 75219
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 752359103
Nicholaos Bellos
Dallas, Texas, 75246
Community Health Care
Fort Lauderdale, Florida, 33306
Immunity Care and Research Inc
Fort Lauderdale, Florida, 33311
HIV Clinical Research Ctr
Fort Lauderdale, Florida, 33316
Houston Clinical Research Network / Div of Montrose Clinic
Houston, Texas, 77006
Clinical Studies of Las Vegas
Las Vegas, Nevada, 89128
AIDS Healthcare Foundation
Los Angeles, California, 900276069
South Shore Hosp
Miami, Florida, 33139
Coastal Carolina Research Ctr
Mt. Pleasant, South Carolina, 29464
Robert Scott MD
Oakland, California, 94609
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985400
Anderson Clinical Research Inc
Reading, Pennsylvania, 19604
Anderson Clinical Research Inc
Rego Park, New York, 11374
Swedish Med Ctr
Seattle, Washington, 98122
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124
Canada2 sites
Clinique Medicale du Quartier Latin
Montreal, Quebec
Clinique Medicale L'Actuele
Montreal, Quebec
About this study
Official title: Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily
Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).
Read the detailed description
Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.
- Conditions
- HIV Infections
- Being tested
- Nelfinavir mesylate, Stavudine, Didanosine
- Keywords
- Didanosine, Drug Therapy, Combination, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Nelfinavir, 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.
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 startMar 1999
- Primary completionMar 1999
- Study completionMar 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002224
- Sponsor's protocol ID
- 039G
- Other IDs
- AI454-158
- 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
- Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily
- ClinicalTrials.gov ID
- NCT00002224
- Acronym / sponsor ID
- 039G
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drug Therapy, Combination, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 1999
- Primary completion
- Mar 1999 (actual)
- Study completion
- Mar 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.
Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).
Detailed description
Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are HIV-positive.
- Are at least 18 years old.
- Have a viral load of at least 5,000 copies/ml and a CD4 count of at least 100 cells/mm3.
Key exclusion criteria (8 listed)
- Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.)
- Have severe diarrhea.
- Are pregnant or breast-feeding.
- Have a history of pancreatic disease or any other serious condition.
- Have hepatitis within 30 days prior to study entry.
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 | – |
| 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 25 Apr 2011.
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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.
24 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 Nelfinavir mesylate, Stavudine and Didanosine in people with HIV Infections, run by Bristol-Myers Squibb at 24 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 4 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 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 24 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?
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.