HIV InfectionsNCT00002035
Double-Blind Comparison of the Efficacy of Continued Zidovudine Versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment With Zidovudine
A study testing Zidovudine and Didanosine in people with HIV Infections, run by Bristol-Myers Squibb at 18 sites in 2 countries.
Trial summary
To compare the efficacy and safety of orally administered didanosine (ddI) with orally administered zidovudine (AZT) in the treatment of patients who exhibit increasing clinical deterioration despite treatment with AZT. 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?
- Zidovudine and Didanosine
- How many people
- 300 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Start not givento Apr 1992
- 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
- Concurrent Medication:
- Allowed for Hematologic toxicity:
- Erythropoietin.
- Colony-Stimulating Factors.
- Allowed for prophylaxis of Pneumocystis carinii pneumonia (PCP):
- Aerosolized pentamidine.
Show all 15Show fewer
- Trimethoprim/sulfamethoxazole.
- Dapsone.
- NOTE:
- If intravenous pentamidine is required for treatment of PCP, study drug should be suspended until one week after completion of intravenous pentamidine.
- Allowed:
- Prophylactic or suppressive therapy begun prior to study entry with the exception of neurotoxic agents (as defined in the protocol).
- Concurrent Treatment:
- Allowed:
- Transfusions for hematologic toxicity.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Active acute AIDS defining infection.
- Clinical evidence of acute pancreatitis in the last two years or chronic pancreatitis.
- Dementia of such severity that patient cannot give informed consent.
- Grade 2 or worse peripheral neuropathy as defined by Targeted Neuropathy Score (Schaumberg).
Show all 39Show fewer
- Prior Cytomegalovirus disease requiring ongoing systemic ganciclovir therapy.
- Extensive Kaposi's sarcoma or other malignancy requiring systemic cytotoxic myelosuppressive or neurotoxic chemotherapy.
- Cardiomyopathy or the need for antiarrhythmic therapy.
- Inability to tolerate at least 600 mg per day of zidovudine (AZT).
- Seizures within the last 6 months or the need for anticonvulsant therapy.
- Concurrent Medication:
- Excluded:
- Ganciclovir (DHPG).
- Myelosuppressive or neurotoxic chemotherapy.
- Antiarrhythmic therapy.
- Anticonvulsant therapy.
- Neurotoxic agents (as defined in the protocol).
- NOTE:
- If intravenous pentamidine is required for treatment of Pneumocystis carinii pneumonia (PCP), study drug should be suspended until 1 week after completion of intravenous pentamidine.
- Patients with the following are excluded:
- Symptoms and conditions defined in the Patient Exclusion Co-Existing Conditions field.
- Average of two sequential CD4 counts from SciCor Clinical Laboratories in the 30 days prior to study entry > 300 cells/mm3.
- Prior Medication:
- Excluded, participation in studies using:
- Dideoxyinosine (ddI).
- 2',3'-Dideoxy-2',3'-didehydrothymidine (d4T).
- Dideoxycytidine (ddC).
- Excluded within one month of study entry:
- Any other experimental antiretroviral compounds.
- Patients must:
- Have documented HIV positivity via ELISA.
- Meet CDC criteria for AIDS or AIDS related complex (ARC).
- Have received zidovudine (AZT) for = or > 6 months and tolerated a dose of at least 500 mg per day without significant hematologic toxicity.
- Have no acute AIDS defining opportunistic infection, but may be receiving suppressive therapy for such infections.
- Demonstrate at least one of the following criteria for clinical deterioration despite AZT therapy within 4 weeks prior to study entry (8 weeks prior for weight loss):
- involuntary weight loss of more than 5 percent of the body weight occurring over the 8 week period prior to study entry, Karnofsky score = or > 50 but demonstrating a fall = or > 20 from previous level of functioning (assessment must be persistent on two occasions at least 14 days apart), unexplained fever of = or > 38 degrees C (despite evaluation defined in protocol) for more than 7 days, appearance of newly diagnosed oral hairy leukoplakia or oral candidiasis, or recurrence of a previously quiescent multidermatomal varicella-zoster, appearance of dermatologic afflictions (e.g. psoriasis, molluscum contagiosum, or newly diagnosed seborrheic dermatitis), appearance of chronic herpetic ulcers not responsive to acyclovir therapy.
- Required:
- Zidovudine (AZT) for = or > 6 months prior to study entry.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
Albany Med College / AIDS Treatment Ctr
Albany, New York, 12203
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Harper Hosp
Detroit, Michigan, 48201
G E Morey Jr
Fort Lauderdale, Florida, 33316
Univ TX Galveston Med Branch
Galveston, Texas, 775550882
Dr Stephen L Green
Hampton, Virginia, 23666
Edward Hines Veterans Administration Hosp
Hines, Illinois, 60141
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226
Yale Univ Med School
New Haven, Connecticut, 06510
VP Med Services / HHCS Research Institute Inc
Orlando, Florida, 32806
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
Med College of Ohio
Toledo, Ohio, 43699
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
About this study
To compare the efficacy and safety of orally administered didanosine (ddI) with orally administered zidovudine (AZT) in the treatment of patients who exhibit increasing clinical deterioration despite treatment with AZT.
- Conditions
- HIV Infections
- Being tested
- Zidovudine, Didanosine
- Keywords
- Didanosine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 completionApr 1992
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
- Masking
- Double blind
- Enrolment
- 300 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
- NCT00002035
- Sponsor's protocol ID
- 039B
- Other IDs
- AI454-010
- Status last verified
- Aug 2011
- First submitted
- 2 Nov 1999
- Last updated
- 5 Aug 2011
- Results posted
- No
Publications
Ruedy N, et al. Results of long term follow-up of a double blind study of ddI vs continued AZT among individuals with CD4s 200-500/mm3. Int Conf AIDS. 1994 Aug 7-12;10(2):16 (abstract no 358B)
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Comparison of the Efficacy of Continued Zidovudine Versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment With Zidovudine
- ClinicalTrials.gov ID
- NCT00002035
- Acronym / sponsor ID
- 039B
- Conditions
- HIV Infections
- Keywords
- Didanosine, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study completion
- Apr 1992 (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.
To compare the efficacy and safety of orally administered didanosine (ddI) with orally administered zidovudine (AZT) in the treatment of patients who exhibit increasing clinical deterioration despite treatment with AZT.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Erythropoietin.
- Colony-Stimulating Factors.
- Allowed for prophylaxis of Pneumocystis carinii pneumonia (PCP):
- Aerosolized pentamidine.
- Trimethoprim/sulfamethoxazole.
Key exclusion criteria (39 listed)
- Active acute AIDS defining infection.
- Clinical evidence of acute pancreatitis in the last two years or chronic pancreatitis.
- Dementia of such severity that patient cannot give informed consent.
- Grade 2 or worse peripheral neuropathy as defined by Targeted Neuropathy Score (Schaumberg).
- Prior Cytomegalovirus disease requiring ongoing systemic ganciclovir therapy.
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 |
|---|---|---|
| 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 5 Aug 2011.
- BackgroundRuedy N, et al. Results of long term follow-up of a double blind study of ddI vs continued AZT among individuals with CD4s 200-500/mm3. Int Conf AIDS. 1994 Aug 7-12;10(2):16 (abstract no 358B)
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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zidovudine and Didanosine in people with HIV Infections, run by Bristol-Myers Squibb at 18 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 15 inclusion and 39 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 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Puerto Rico. 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 NCT00002035, 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 5 Aug 2011.