Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004585
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-15
Brief Title:
A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase IV Open-Label Multicenter Study of the Efficacy and Safety of Quadruple Combination Antiretroviral Therapy With Combivir Lamivudine 150mgZidovudine 300mg BID Ziagen Abacavir 300mg BID and Sustiva Efavirenz 600mg QD for 24 Weeks Followed by the Triple Nucleoside Combination Tablet Abacavir 300mgLamivudine 150mgZidovudine 300mg BID Plus Sustiva Efavirenz 600mg QD for 24 Weeks in HIV-Infected Adults
Status:
COMPLETED
Status Verified Date:
2000-11
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:
The purpose of this study is to see if a certain combination of anti-HIV drugs is safe and effective in HIV-infected patients The drug combination includes a tablet containing lamivudine and zidovudine called Combivir plus abacavir plus efavirenz
Detailed Description:
Patients take open-label Combivir plus abacavir plus efavirenz for 48 weeks AS PER AMENDMENT 42000 Patients taking Combivir plus abacavir at Week 24 receive the triple-nucleoside-combination tablet TCT abacavirlamivudinezidovudine beginning at Week 24 and continuing through Week 48 in combination with efavirenz or nevirapine if the patient has made a protocol-allowed substitution Patients not taking Combivir and abacavir at Week 24 will continue in the study on the substituted protocol-allowed drug regimen provided their plasma HIV RNA is below 400 copiesml at 24 weeks Following enrollment on Study Day 1 on-study evaluations virologic and safety are performed at Weeks 2 4 8 12 16 and then every 8 weeks through Week 48 end of study CD4 evaluations are performed at baseline and at Weeks 4 8 and then every 8 weeks through Week 48 Immune reconstitution testing is performed at baseline and at Weeks 12 24 and 48 Patients complete the PMAQ7 version 11 medication adherence questionnaire at Weeks 2 8 12 24 and 48 or at their last study visit All patients are requested to return for a post-study follow-up evaluation 2 to 4 weeks after the last on-study visit Patients must have a plasma HIV RNA less than 400 copiesml at Week 24 in order to continue in the study
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 |
|---|---|---|---|
| COL30336 | None | None | None |