Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000659
Status:
TERMINATED
Last Update Posted:
2011-03-14
First Post:
1999-11-02
Brief Title:
A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex ARC
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex ARC
Status:
TERMINATED
Status Verified Date:
1990-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Part 1A To find the dose of zidovudine AZT that causes less than a 50 percent drop in HIV-1 p24 antigen levels in patients with AIDS and advanced AIDS related complex ARC to determine the pharmacokinetics blood levels of rsCD4 administered in combination with AZT Parts 1B and 2 To test for additive or synergistic activity between rsCD4 and AZT as judged by falls in HIV-1 p24 antigen levels and to evaluate the safety of rsCD4 and AZT in patients with AIDS and advanced ARC
AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without toxicity The most clinically significant toxicity is dose related inhibition of bone marrow function Furthermore HIV-1 isolates from patients treated for more than 6 months with AZT have now been found which appear to have reduced sensitivity to AZT The incidence of toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability to administer AZT long-term to patients with AIDS and advanced ARC Recombinant soluble CD4 rCD4 has shown antiretroviral effects and has been shown to be safe when given to AIDS and ARC patients either as a single agent or in combination with AZT
AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without toxicity The most clinically significant toxicity is dose related inhibition of bone marrow function Furthermore HIV-1 isolates from patients treated for more than 6 months with AZT have now been found which appear to have reduced sensitivity to AZT The incidence of toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability to administer AZT long-term to patients with AIDS and advanced ARC Recombinant soluble CD4 rCD4 has shown antiretroviral effects and has been shown to be safe when given to AIDS and ARC patients either as a single agent or in combination with AZT
Detailed Description:
AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without toxicity The most clinically significant toxicity is dose related inhibition of bone marrow function Furthermore HIV-1 isolates from patients treated for more than 6 months with AZT have now been found which appear to have reduced sensitivity to AZT The incidence of toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability to administer AZT long-term to patients with AIDS and advanced ARC Recombinant soluble CD4 rCD4 has shown antiretroviral effects and has been shown to be safe when given to AIDS and ARC patients either as a single agent or in combination with AZT
Part 1A Twenty p24 patients with AIDS or advanced ARC are randomized to 4 dosing groups of 5 patients each Patients are treated with AZT for 6 weeks at ranging doses to determine a minimally effective dose MED At the end of week 6 each patient is sequentially assigned to 1 of 5 groups of rCD4 AZT combination treatment The first 3 patients to complete treatment through week 6 are treated in group A the next 3 patients in group B and so on The treatment period is 4 weeks Each patient continues on his or her AZT dose as initially administered The highest dose of AZT that produces less than a 50 percent drop in HIV-1 p24 antigen levels in at least 3 of 5 patients over 6 weeks will be the MED of AZT and will be known as the AZT MED After the MED is determined Part 1B begins Part 1B 20 patients are randomized to 2 different dosing groups Group 5 AZT MED weeks 1 to 8 then AZT MED plus rCD4 weeks 9 to 16 Group 6 AZT MED plus rCD4 weeks 1 to 8 then AZT MED weeks 9 to 16 Part 2 Part 2 begins once accrual to Part 1B is completed If fewer than 10 of 20 patients exhibit a drop of at least 50 percent in p24 antigen level after receiving AZT and rsCD4 combination treatment entry to Part 2 will be interrupted and the study design will be reevaluated In Part 2 10 patients are randomly assigned to one of four groups Patients within each group receive two 8 week treatment courses These two treatment courses are 8 weeks with the AZT MED alone and 8 weeks of treatment with the combination of the AZT MED plus rCD4
Part 1A Twenty p24 patients with AIDS or advanced ARC are randomized to 4 dosing groups of 5 patients each Patients are treated with AZT for 6 weeks at ranging doses to determine a minimally effective dose MED At the end of week 6 each patient is sequentially assigned to 1 of 5 groups of rCD4 AZT combination treatment The first 3 patients to complete treatment through week 6 are treated in group A the next 3 patients in group B and so on The treatment period is 4 weeks Each patient continues on his or her AZT dose as initially administered The highest dose of AZT that produces less than a 50 percent drop in HIV-1 p24 antigen levels in at least 3 of 5 patients over 6 weeks will be the MED of AZT and will be known as the AZT MED After the MED is determined Part 1B begins Part 1B 20 patients are randomized to 2 different dosing groups Group 5 AZT MED weeks 1 to 8 then AZT MED plus rCD4 weeks 9 to 16 Group 6 AZT MED plus rCD4 weeks 1 to 8 then AZT MED weeks 9 to 16 Part 2 Part 2 begins once accrual to Part 1B is completed If fewer than 10 of 20 patients exhibit a drop of at least 50 percent in p24 antigen level after receiving AZT and rsCD4 combination treatment entry to Part 2 will be interrupted and the study design will be reevaluated In Part 2 10 patients are randomly assigned to one of four groups Patients within each group receive two 8 week treatment courses These two treatment courses are 8 weeks with the AZT MED alone and 8 weeks of treatment with the combination of the AZT MED plus rCD4
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C89-013-P | None | None | None |