AIDS Dementia ComplexPhase 2NCT00000657
Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex
A Phase 2 study testing Zidovudine and Didanosine in people with AIDS Dementia Complex and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.
Trial summary
To compare the safety and effectiveness of orally administered didanosine (ddI) with high dose orally administered zidovudine (AZT) in patients who develop or exhibit progression of the AIDS dementia complex (ADC) and who have not previously been intolerant to AZT at doses of up to 1000 mg/day. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- AIDS Dementia Complex, HIV Infections
- What is being tested?
- Zidovudine and Didanosine
- How many people
- 80 participants
- Where
- 13 sitesUnited States
- Study dates
- Start not givento Sep 1992
- Phase
- Phase 2
- 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:
- Chronic suppressive therapy for herpes simplex virus, cytomegalovirus, Candida albicans, and Salmonella.
- Prophylactic therapy for Pneumocystis carinii pneumonia.
- Maintenance anticonvulsant therapy following a seizure in the context of the AIDS dementia complex.
- Isoniazid only if no acceptable alternative therapy is available.
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- Judicious use of benzodiazepines, tricyclics, and other antidepressants is allowed but a stable dose level should be obtained prior to entry and maintained throughout the trial.
- In patients for whom it is medically necessary to initiate or alter therapy with these drugs during the initial 16 week study period, data will not be used in the study.
- Metronidazole for single courses of therapy not to exceed 14 days within consecutive 90-day intervals, the first of which begins at the initiation of the study.
- Erythropoietin for patients under the relevant Treatment IND.
- Symptomatic therapies (such as analgesics, antihistamines, antiemetics, antidiarrheal agents).
- Allowed but not encouraged:
- trimethoprim /sulfamethoxazole (T/S) or other sulfonamides.
- Patients must have the following:
- Screened for other causes of dementia.
- Stage 1, 2, or 3 AIDS dementia complex.
- Estimated premorbid IQ of at least 70.
- Anti-HIV antibody or HIV in blood and/or cerebrospinal fluid.
- If prior history of positive syphilis serology, should have been treated with appropriate course of antibiotics; if not, such treatment should be administered prior to pretreatment screening.
- Not have previously shown intolerance to zidovudine (AZT).
- Able (or parent and/or guardian able) to provide written consent.
- Allowed:
- Basal cell carcinoma, in situ carcinoma of the cervix, Kaposi's sarcoma without evidence of visceral involvement or not requiring systemic chemotherapy.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Grade 3 neuropathy, based on the Neuropathy Targeted Symptom.
- Questionnaire, or patients with any moderate abnormality indicative of peripheral neuropathy including stocking loss of sensation (to sharp pain, light touch, or vibration), distal extremity weakness (< 4/5), or absent ankle jerks.
- History of present or past acute or chronic pancreatitis.
- Active, symptomatic AIDS-defining opportunistic infection and requiring any ongoing maintenance therapy for confounding neurologic disease.
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- Severe premorbid psychiatric illness including bipolar illness, schizophrenia, and electroconvulsive therapy.
- Previous neurological disease unrelated to HIV infection:
- multiple sclerosis, documented stroke, degenerative disease.
- Patients with chronic seizure disorders or head injury will only be excluded if the condition results in functional impairment or is likely to interfere with the evaluation.
- Concurrent or previous central nervous system infections or neoplasms as revealed by Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) scan or cerebrospinal fluid analysis (such as toxoplasmosis, primary or metastatic Central Nervous System (CNS) lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, tuberculous Central Nervous System (CNS) infections, and untreated neurosyphilis).
- Concurrent Medication:
- Excluded:
- Intravenous pentamidine. DHPG (Ganciclovir) should not be co-administered.
- Monoamine oxidase (MAO) inhibitors, phenothiazines, butyrophenones, barbiturates, amphetamines.
- Oral acidifying agents.
- Patients with the following are excluded:
- Neoplasms not specifically allowed.
- Grade 3 neuropathy.
- History of present or past acute or chronic pancreatitis.
- Active, symptomatic AIDS-defining opportunistic infection.
- Requiring any ongoing maintenance therapy for confounding neurologic disease.
- Conditions listed under Exclusion Co-existing Conditions.
- Prior Medication:
- Excluded within 30 days of study entry:
- Anti-HIV therapy other than zidovudine (AZT).
- Biologic response modifiers.
- Corticosteroids.
- Drugs toxic to peripheral nerves.
- Investigative drugs.
- Neurotoxic drugs.
- Excluded:
- Dideoxycytidine (ddC).
- Active alcohol or drug abuse or methadone maintenance sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy and evaluations.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Univ of Minnesota
Minneapolis, Minnesota, 55455
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Mount Sinai Med Ctr
New York, New York, 10029
Univ of Rochester Medical Center
Rochester, New York, 14642
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
San Francisco Gen Hosp
San Francisco, California, 941102859
Univ of Washington
Seattle, Washington, 981224304
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
To compare the safety and effectiveness of orally administered didanosine (ddI) with high dose orally administered zidovudine (AZT) in patients who develop or exhibit progression of the AIDS dementia complex (ADC) and who have not previously been intolerant to AZT at doses of up to 1000 mg/day.
HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system. ADC may be caused by some action of the AIDS virus on the nervous system, although similar problems can be caused by other infections because the AIDS virus lowers the body's ability to fight other infections. It is important to determine whether symptoms are due to ADC or to some other infection since treatment varies for different conditions. AZT has been shown to be beneficial to people with ADC although its effectiveness has only been studied in a small number of patients. Studies suggest that higher doses of AZT are more likely to be effective than standard doses in improving symptoms of ADC.
Read the detailed description
HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system. ADC may be caused by some action of the AIDS virus on the nervous system, although similar problems can be caused by other infections because the AIDS virus lowers the body's ability to fight other infections. It is important to determine whether symptoms are due to ADC or to some other infection since treatment varies for different conditions. AZT has been shown to be beneficial to people with ADC although its effectiveness has only been studied in a small number of patients. Studies suggest that higher doses of AZT are more likely to be effective than standard doses in improving symptoms of ADC.
Patients are randomly assigned to receive either oral ddI or oral AZT.
- Conditions
- AIDS Dementia Complex, HIV Infections
- Being tested
- Zidovudine, Didanosine
- Keywords
- Didanosine, Drug Evaluation, Drugs, Investigational, AIDS Dementia Complex, Zidovudine
- Medical subject headings
- AIDS Dementia Complex, HIV Infections
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 completionSep 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 AIDS Dementia ComplexStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Bristol-Myers Squibb, Glaxo Wellcome
- Responsible party
- Sponsor
- Investigators
- C Hall, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000657
- Sponsor's protocol ID
- ACTG 140
- Other IDs
- 11115
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 3 Nov 2021
- Results posted
- No
Publications
Brouwers P, Hendricks M, Lietzau JA, Pluda JM, Mitsuya H, Broder S, Yarchoan R. Effect of combination therapy with zidovudine and didanosine on neuropsychological functioning in patients with symptomatic HIV disease: a comparison of simultaneous and alternating regimens. AIDS. 1997 Jan;11(1):59-66. doi: 10.1097/00002030-199701000-00009.
PubMed 9110076
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex
- ClinicalTrials.gov ID
- NCT00000657
- Acronym / sponsor ID
- ACTG 140
- Conditions
- AIDS Dementia Complex, HIV Infections
- Keywords
- Didanosine, Drug Evaluation, Drugs, Investigational, AIDS Dementia Complex, Zidovudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Bristol-Myers Squibb, Glaxo Wellcome
- Study completion
- Sep 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 safety and effectiveness of orally administered didanosine (ddI) with high dose orally administered zidovudine (AZT) in patients who develop or exhibit progression of the AIDS dementia complex (ADC) and who have not previously been intolerant to AZT at doses of up to 1000 mg/day.
HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system. ADC may be caused by some action of the AIDS virus on the nervous system, although similar problems can be caused by other infections because the AIDS virus lowers the body's ability to fight other infections. It is important to determine whether symptoms are due to ADC or to some other infection since treatment varies for different conditions. AZT has been shown to be beneficial to people with ADC although its effectiveness has only been studied in a small number of patients. Studies suggest that higher doses of AZT are more likely to be effective than standard doses in improving symptoms of ADC.
Detailed description
HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system. ADC may be caused by some action of the AIDS virus on the nervous system, although similar problems can be caused by other infections because the AIDS virus lowers the body's ability to fight other infections. It is important to determine whether symptoms are due to ADC or to some other infection since treatment varies for different conditions. AZT has been shown to be beneficial to people with ADC although its effectiveness has only been studied in a small number of patients. Studies suggest that higher doses of AZT are more likely to be effective than standard doses in improving symptoms of ADC.
Patients are randomly assigned to receive either oral ddI or oral 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 (23 listed)
- Chronic suppressive therapy for herpes simplex virus, cytomegalovirus, Candida albicans, and Salmonella.
- Prophylactic therapy for Pneumocystis carinii pneumonia.
- Maintenance anticonvulsant therapy following a seizure in the context of the AIDS dementia complex.
- Isoniazid only if no acceptable alternative therapy is available.
- Judicious use of benzodiazepines, tricyclics, and other antidepressants is allowed but a stable dose level should be obtained prior to entry and maintained throughout the trial.
Key exclusion criteria (34 listed)
- Grade 3 neuropathy, based on the Neuropathy Targeted Symptom.
- Questionnaire, or patients with any moderate abnormality indicative of peripheral neuropathy including stocking loss of sensation (to sharp pain, light touch, or vibration), distal extremity weakness (< 4/5), or absent ankle jerks.
- History of present or past acute or chronic pancreatitis.
- Active, symptomatic AIDS-defining opportunistic infection and requiring any ongoing maintenance therapy for confounding neurologic disease.
- Severe premorbid psychiatric illness including bipolar illness, schizophrenia, and electroconvulsive 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 3 Nov 2021.
- Background: PubMed 9110076Brouwers P, Hendricks M, Lietzau JA, Pluda JM, Mitsuya H, Broder S, Yarchoan R. Effect of combination therapy with zidovudine and didanosine on neuropsychological functioning in patients with symptomatic HIV disease: a comparison of simultaneous and alternating regimens. AIDS. 1997 Jan;11(1):59-66. doi: 10.1097/00002030-199701000-00009.
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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.
C Hall study chair
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zidovudine and Didanosine in people with AIDS Dementia Complex and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 23 inclusion and 34 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 3 Nov 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NCT00000657, 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 3 Nov 2021.