Comparison of ddI Versus Zidovudine in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00000979
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (71)
Children's Hosp of Los Angeles/UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
🇺🇸Palo Alto, California, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Stanford Univ School of Medicine
🇺🇸Stanford, California, United States
Olive View Med Ctr
🇺🇸Sylmar, California, United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
🇺🇸Sylmar, California, United States
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
Mountain States Regional Hemophilia Ctr / Univ of Colorado
🇺🇸Denver, Colorado, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Scroll for more (61 remaining)Children's Hosp of Los Angeles/UCLA Med Ctr🇺🇸Los Angeles, California, United States