Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342355
Status:
COMPLETED
Last Update Posted:
2013-05-21
First Post:
2006-06-19
Brief Title:
Antiretroviral Therapy for Advanced HIV Disease in South Africa
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Randomized Open-Label 2x2 Factorial Study to Compare the Safety and Efficacy of Different Combination Antiretroviral Therapy Regimens in Treatment Naive Patients With Advanced HIV Disease andor CD4 Cell Counts Less Than 200 CellsMicroL
Status:
COMPLETED
Status Verified Date:
2013-04
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:
This study will determine how well four different antiretroviral drug therapies work in patients with advanced HIV disease The trial is part of the South Africa-US Project Phidisa Programme - a collaboration between the South African Military Health Service SAMHS of the South African National Defense Force SANDF the US Department of Defense and the US National Institutes of Health - to help prevent HIV transmission among South African military and civilian employees and their families
Members of the SANDF with HIV infection may be eligible for this study HIV-infected family members who are 14 years of age and older may also participate All participants must have a CD4 count of less than 200 or an AIDS-defining illness
Participants are randomly assigned to one of the following four antiretroviral drug regimens which require taking 5 pills or more every day
AZT zidovudine ddl didanosine EFV efavirenz
AZT zidovudine ddl didanosine rLPV lopinavirritonavir
D4T stavudine 3TC lamivudine EFV efavirenz
D4T stavudine 3TC lamivudine rLPV lopinavirritonavir
Patients are followed for up to 6 years Clinic visits are scheduled once a month for the first 3 months and then once every 3 months for the next five years Patients undergo a medical history physical examination and blood tests at each visit and complete questionnaires of behavior quality of life and force readiness every year
Members of the SANDF with HIV infection may be eligible for this study HIV-infected family members who are 14 years of age and older may also participate All participants must have a CD4 count of less than 200 or an AIDS-defining illness
Participants are randomly assigned to one of the following four antiretroviral drug regimens which require taking 5 pills or more every day
AZT zidovudine ddl didanosine EFV efavirenz
AZT zidovudine ddl didanosine rLPV lopinavirritonavir
D4T stavudine 3TC lamivudine EFV efavirenz
D4T stavudine 3TC lamivudine rLPV lopinavirritonavir
Patients are followed for up to 6 years Clinic visits are scheduled once a month for the first 3 months and then once every 3 months for the next five years Patients undergo a medical history physical examination and blood tests at each visit and complete questionnaires of behavior quality of life and force readiness every year
Detailed Description:
This is a randomized open label 2x2 factorial study of four regimens of initial therapy
I AZT ddl EFV
II AZT ddl rLPV
III D4T 3TC EFV
IV D4T 3TC rLPV
Eligible patients will commence their randomly allocated study drugs as soon as possible after randomization Episodes of treatment limiting toxicity will be managed in keeping with protocol specified guidelines
Patients who experience treatment failures as specified in the protocol will be managed by changing their regimen to that corresponding to one of the other treatment groups
I AZT ddl EFV
II AZT ddl rLPV
III D4T 3TC EFV
IV D4T 3TC rLPV
Eligible patients will commence their randomly allocated study drugs as soon as possible after randomization Episodes of treatment limiting toxicity will be managed in keeping with protocol specified guidelines
Patients who experience treatment failures as specified in the protocol will be managed by changing their regimen to that corresponding to one of the other treatment groups
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 |
|---|---|---|---|
| 04-I-N094 | REGISTRY | NCT00342355 | None |