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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000979 |
To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS, advanced AIDS-related complex (ARC), or asymptomatic infection with CD4 counts < 200 cells/mm3.
AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicity than AZT.
Condition | Intervention | Phase |
HIV Infections |
Drug: Zidovudine Drug: Didanosine |
Phase II |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Zidovudine Didanosine |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Comparison of 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine in Therapy of Patients With HIV Infection |
Estimated Enrollment: | 1500 |
AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicity than AZT.
AMENDED: 9/28/90 Patients are assigned to one of 2 treatments under a double-blind, randomly allocated, experimental design if their duration of prior AZT therapy is 0 to 16 weeks. (Patients who entered with no more than 16 weeks prior AZT and who were randomized to ddI will continue to be dosed at that level, adjusted for weight, and followed as originally planned.) Patients are assigned to one of 3 treatments as explained prior to this amendment if their duration of prior to AZT therapy is greater than 16 weeks. Original design: Patients are assigned to one of three treatments under a double-blind randomly allocated experimental design. ddI will be administered at two dose levels.
It is anticipated that patients will be seen as outpatients every 2 weeks for the first 4 weeks of the study and monthly thereafter. This study continues for at least 18 months after the entry of the first subject.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Maintenance therapy for active AIDS defining opportunistic infections for patients with 9 to 47 weeks' experience with zidovudine (AZT).
Treatment of opportunistic infections with other than sulfonamide containing drugs:
Intravenous acyclovir for up to 10 days. Erythropoietin for patients under the relevant treatment IND. Analgesics, antihistamines, antiemetics, antidiarrheal agents for symptomatic therapy for toxicities.
Isoniazid (INH) if no other acceptable therapy is available.
Metronidazole may be used for single courses of therapy not to exceed 14 days within consecutive 90 day intervals. Note:
Concurrent Treatment:
Allowed:
Patients must:
Allowed:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or diseases are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Excluded within 14 days of study entry:
Excluded within 30 days of study entry:
Excluded within 90 days of study entry:
Prior Treatment:
Excluded within 14 days of study entry:
Active alcohol or drug abuse sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.
Show 71 Study Locations |
National Institute of Allergy and Infectious Diseases (NIAID) |
Bristol-Myers Squibb |
Study Chair: | R Dolin | |
Study Chair: | M Fischl |
Click here for more information about zidovudine 
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Click here for more information about didanosine 
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Study ID Numbers: | ACTG 116, 070V1, ACTG 116-A, ACTG 116-B/117, AI454-008 |
First Received: | November 2, 1999 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00000979 |
Health Authority: | United States: Federal Government |
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