Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000838
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine Stavudine or Didanosine
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 Randomized Study of the Antiviral Activity and Resistance Interactions of Lamivudine 3TC in Combination With Zidovudine AZT Stavudine d4T or Didanosine ddI Versus Monotherapy With ddI or d4T in HIV-Infected Individuals With 200 - 600 CD4 Cellsmm3 and No Previous Nucleoside Experience
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To evaluate the efficacy safety and pharmacokinetics of lamivudine 3TC combined with zidovudine AZT stavudine d4T or didanosine ddI in comparison with d4T or ddI monotherapy in HIV-infected patients with no prior nucleoside therapy
3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations One explanation is that the M184V mutation which confers resistance to 3TC suppresses AZT resistance This benefit of 3TC may not extend to combination therapy with other nucleoside analogs
3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations One explanation is that the M184V mutation which confers resistance to 3TC suppresses AZT resistance This benefit of 3TC may not extend to combination therapy with other nucleoside analogs
Detailed Description:
3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations One explanation is that the M184V mutation which confers resistance to 3TC suppresses AZT resistance This benefit of 3TC may not extend to combination therapy with other nucleoside analogs
Patients are randomized to either a ddI limb or d4T limb then randomized a second time to one of six treatment arms as follows ddI alone d4T alone 3TCAZT on both ddI and d4T limbs 3TCddI and 3TCd4T Treatment is given for 48 weeks At study week 24 patients on monotherapy will have 3TC added to their regimen in a blinded fashion
PER AMENDMENT 101896 A treatment extension phase has been added to the study design in order to allow subjects who complete 48 weeks of therapy to remain on their same blinded treatment until approximately 2 months after the last enrolled subject completes 48 weeks on the study
Patients are randomized to either a ddI limb or d4T limb then randomized a second time to one of six treatment arms as follows ddI alone d4T alone 3TCAZT on both ddI and d4T limbs 3TCddI and 3TCd4T Treatment is given for 48 weeks At study week 24 patients on monotherapy will have 3TC added to their regimen in a blinded fashion
PER AMENDMENT 101896 A treatment extension phase has been added to the study design in order to allow subjects who complete 48 weeks of therapy to remain on their same blinded treatment until approximately 2 months after the last enrolled subject completes 48 weeks on the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11281 | REGISTRY | DAIDS ES Registry Number | None |