Antiretroviral Therapy for Advanced HIV Disease in South Africa
- Conditions
- HIV
- Interventions
- Registration Number
- NCT00342355
- 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-U.S. Project Phidisa Programme - a collaboration between the South African Military Health Service (SAMHS) of the South African National Defense Force (SANDF), the U.S. Department of Defense, and the U.S. 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) + r/LPV (lopinavir/ritonavir)
* D4T (stavudine) + 3TC (lamivudine) + EFV (efavirenz)
* D4T (stavudine) + 3TC (lamivudine) + r/LPV (lopinavir/ritonavir)
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 + r/LPV
III. D4T + 3TC + EFV
IV. D4T + 3TC + r/LPV
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1771
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description AZT+DDI+r/LPV Zidovudine Zidovudine,Didanosine,Lopinavir/Ritonavir(AZT 600 mg once daily,DDI 100 mg twice daily,r/LPV 400mg/100mg twice daily) d4T+3TC+EFV Stavudine Stavudine,Lamivudine,Efavirenz(d4T 40 mg twice daily,3TC 300 mg once daily,EFV 600 mg once daily) AZT+DDI+r/LPV Lopinavir/Ritonavir Zidovudine,Didanosine,Lopinavir/Ritonavir(AZT 600 mg once daily,DDI 100 mg twice daily,r/LPV 400mg/100mg twice daily) d4T+3TC+r/LPV Lopinavir/Ritonavir Stavudine,Lamivudine,Lopinavir/Ritonavir(d4T 40m mg twice daily,3TC 300 mg once daily,r/LPV 400mg/100mg twice daily) d4T+3TC+EFV Lamivudine Stavudine,Lamivudine,Efavirenz(d4T 40 mg twice daily,3TC 300 mg once daily,EFV 600 mg once daily) AZT+DDI+EFV Zidovudine Zidovudine,Didanosine,Efavirenz ( Zidovudine 600 mg once daily,Didanosine \<60 kg/125 mg twice daily or \>60kg/200 mg twice daily,Efavirenz 600 mg once daily) AZT+DDI+EFV Didanosine Zidovudine,Didanosine,Efavirenz ( Zidovudine 600 mg once daily,Didanosine \<60 kg/125 mg twice daily or \>60kg/200 mg twice daily,Efavirenz 600 mg once daily) AZT+DDI+EFV Efavirenz Zidovudine,Didanosine,Efavirenz ( Zidovudine 600 mg once daily,Didanosine \<60 kg/125 mg twice daily or \>60kg/200 mg twice daily,Efavirenz 600 mg once daily) AZT+DDI+r/LPV Didanosine Zidovudine,Didanosine,Lopinavir/Ritonavir(AZT 600 mg once daily,DDI 100 mg twice daily,r/LPV 400mg/100mg twice daily) d4T+3TC+EFV Efavirenz Stavudine,Lamivudine,Efavirenz(d4T 40 mg twice daily,3TC 300 mg once daily,EFV 600 mg once daily) d4T+3TC+r/LPV Lamivudine Stavudine,Lamivudine,Lopinavir/Ritonavir(d4T 40m mg twice daily,3TC 300 mg once daily,r/LPV 400mg/100mg twice daily) d4T+3TC+r/LPV Stavudine Stavudine,Lamivudine,Lopinavir/Ritonavir(d4T 40m mg twice daily,3TC 300 mg once daily,r/LPV 400mg/100mg twice daily)
- Primary Outcome Measures
Name Time Method Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens. January 2004 until March 31 2008 Progression of disease, AIDS, or death in treatment naive patients with advanced HIV diagnosis will be evaluated in the four randomly assigned regimens.
- Secondary Outcome Measures
Name Time Method Serious Adverse Events January 2004 until March 31, 2008 Safety outcomes in four different randomly assigned regimens
Trial Locations
- Locations (7)
Mtubatuba SIckbay
🇿🇦Kwazulu-Natal, South Africa
Umtata Sickbay
🇿🇦Eastaern Cape, South Africa
South African Military Health Services (SAMHS)
🇿🇦Centurion, South Africa
3 Military Hospital
🇿🇦Free State, South Africa
1 Military Hospital
🇿🇦Gauteng, South Africa
2 Military Hospital
🇿🇦Western Cape, South Africa
Phalaborwa Sickbay
🇿🇦Limpopo, South Africa