HIV InfectionsNCT00002207
A Comparison of Two Dose Levels of Didanosine Used in Combination With Stavudine in HIV-Infected Patients
A study testing Stavudine and Didanosine in people with HIV Infections, run by Bristol-Myers Squibb at 13 sites in United States.
Trial summary
The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This study also examines the safety of giving ddI with d4T in the short-term. 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?
- Stavudine and Didanosine
- How many people
- Not given
- Where
- 13 sitesUnited States
- Study dates
- Feb 2004to Feb 2004
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- Documented HIV infection.
- CD4 cell count of at least 100 cells/mm3.
- Plasma HIV RNA count of 10,000 copies/ml or more within 14 days prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions and symptoms are excluded:
- Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment.
- Bilateral peripheral neuropathy or signs and symptoms of bilateral peripheral neuropathy greater than or equal to Grade 2 at the time of screening.
- Inability to tolerate oral medication.
- Any other clinical condition that would preclude compliance with dosing requirements.
Show all 20Show fewer
- Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis.
- Intractable diarrhea (6 or more loose stools/day for more than 7 consecutive days) within 30 days prior to study entry.
- Proven or suspected acute hepatitis within 30 days prior to study entry.
- 1. Potent neurotoxic drugs, such as vincristine and thalidomide.
- Other anti-HIV therapy.
- 1. Prophylaxis for pneumocystis carinii pneumonia (PCP) is strongly recommended for patients with CD4 cell counts less than or equal to 200/mm3 or who have had a prior episode of PCP.
- Immunizations recommended by ACIP for routine practice.
- Erythropoietin and G-CSF are allowed if myelosuppression emerges on study.
- 1. Any antiretroviral therapy.
- Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.
- 1. Any prior antiretroviral therapy.
- Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.
- Active alcohol or substance abuse that would prevent adequate compliance or would increase the risk of pancreatitis.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Clinsites / Sorra Research Ctr
Birmingham, Alabama, 35203
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Univ of Texas Med Branch
Galveston, Texas, 775550835
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Houston Clinical Research Network
Houston, Texas, 77006
Indiana Univ School of Medicine / Dept of Infect Dis
Indianapolis, Indiana, 46202
New Jersey Community Research Initiative
Newark, New Jersey, 07103
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213
Fanno Creek Clinic
Portland, Oregon, 97219
Dr Iraj Mirshahi
Richmond, Virginia, 23220
ID Care Inc
Somerville, New Jersey, 08876
Shared Med Research Foundation
Tarzana, California, 91356
Medicine Faculty Associates
Ypsilanti, Michigan, 48197
About this study
Official title: A Randomized, Double-Blind Study of the Antiviral Activity of Once-Daily and Twice-Daily Dosing of Didanosine in Combination With Twice-Daily Dosing of Stavudine in HIV-Infected Subjects
The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This study also examines the safety of giving ddI with d4T in the short-term.
Read the detailed description
Patients are randomized to receive ddI given either qd or bid in combination with d4T given bid (no doses specified).
- Conditions
- HIV Infections
- Being tested
- Stavudine, Didanosine
- Keywords
- Didanosine, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 startFeb 2004
- Primary completionFeb 2004
- Study completionFeb 2004
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002207
- Sponsor's protocol ID
- 039D
- Other IDs
- AI454-143
- Status last verified
- Apr 2011
- First submitted
- 2 Nov 1999
- Last updated
- 25 Apr 2011
- Results posted
- No
Publications
Mobley JE, Pollard RB, Schrader S, Adler MH, Kelleher T, McLaren C. Virological and immunological responses to once-daily dosing of didanosine in combination with stavudine. AI454-143 Team. AIDS. 1999 Jul 30;13(11):F87-93. doi: 10.1097/00002030-199907300-00003.
PubMed 10449279
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, Double-Blind Study of the Antiviral Activity of Once-Daily and Twice-Daily Dosing of Didanosine in Combination With Twice-Daily Dosing of Stavudine in HIV-Infected Subjects
- ClinicalTrials.gov ID
- NCT00002207
- Acronym / sponsor ID
- 039D
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (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 effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This study also examines the safety of giving ddI with d4T in the short-term.
Detailed description
Patients are randomized to receive ddI given either qd or bid in combination with d4T given bid (no doses specified).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented HIV infection.
- CD4 cell count of at least 100 cells/mm3.
- Plasma HIV RNA count of 10,000 copies/ml or more within 14 days prior to study entry.
Key exclusion criteria (20 listed)
- Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment.
- Bilateral peripheral neuropathy or signs and symptoms of bilateral peripheral neuropathy greater than or equal to Grade 2 at the time of screening.
- Inability to tolerate oral medication.
- Any other clinical condition that would preclude compliance with dosing requirements.
- History of acute or chronic pancreatitis.
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 |
|---|---|---|
| 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.
- Background: PubMed 10449279Mobley JE, Pollard RB, Schrader S, Adler MH, Kelleher T, McLaren C. Virological and immunological responses to once-daily dosing of didanosine in combination with stavudine. AI454-143 Team. AIDS. 1999 Jul 30;13(11):F87-93. doi: 10.1097/00002030-199907300-00003.
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stavudine and Didanosine in people with HIV Infections, run by Bristol-Myers Squibb at 13 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 20 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 13 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?
On the ClinicalTrials.gov record for NCT00002207, 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 25 Apr 2011.