Antiretroviral Therapy for Advanced HIV Disease in South Africa
HIV
About this trial
This is an interventional treatment trial for HIV focused on measuring Protease Inhibitors, Reverse Transcriptase Inhibitors, AIDS, Opportunistic Infections, Resource-Poor
Eligibility Criteria
INCLUSION CRITERIA: Uniformed SANDF personnel or family members of SANDF personnel who are registered as eligible for health services from the SAMHS. HIV positive as diagnosed and/or confirmed in PHIDISA I OR documented HIV infection from an accredited source. CD4+ cell count less than 200 cells/microL (or less than or equal to 14% for patients post-splenectomy) AND/OR any AIDS defining illness currently or historically. Patients with pulmonary tuberculosis must have a CD4+ cell count less than 200 cells/microL. Patients with KS must have a CD4+ cell count less than 200 cells/microL unless their sarcoma is progressive and/or requires chemotherapy. Antiretroviral treatment naive (less than 7 days cumulative exposure to any antiretroviral drug) or treated for post-exposure prophylaxis without becoming HIV infected at that time. Laboratory variables as follows: Haemoglobin greater than or equal to 9.0g/dL for men and greater than or equal to 8.0g/dL for women. Absolute neutrophil count greater than or equal to 500 cells/microL. Platelet count greater than or equal to 25,000/mm(3). Serum transaminase (ALT or AST) less than or equal to 5 times upper limit of normal (ULN). 14 years or older. Likely to be compliant with study procedures and clinical visits in the opinion of the clinical investigator (guidance is provided in the protocol to assist clinicians in making this decision). Have completed the PHIDISA treatment adherence counseling session. Provision of written informed consent. EXCLUSION CRITERIA: Any history of pancreatitis or serious pathology indicative of increased risk for pancreatitis. Current requirement for use of a medication that is contra-indicated with the PHIDISA II study drugs. Where possible, alternate therapies should be selected in order to facilitate randomization. Patients entering the study with tuberculosis should defer screening and randomization until successful completion of an induction course of anti-mycobacterium therapy including rifampicin. As appropriate this patient could recommence screening when starting the maintenance regimen of anti-tubercular drugs excluding rifampicin. Pregnancy (following delivery, such women may be enrolled).
Sites / Locations
- South African Military Health Services (SAMHS)
- Umtata Sickbay
- 3 Military Hospital
- 1 Military Hospital
- Mtubatuba SIckbay
- Phalaborwa Sickbay
- 2 Military Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
AZT+DDI+EFV
AZT+DDI+r/LPV
d4T+3TC+EFV
d4T+3TC+r/LPV
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)
Zidovudine,Didanosine,Lopinavir/Ritonavir(AZT 600 mg once daily,DDI 100 mg twice daily,r/LPV 400mg/100mg twice daily)
Stavudine,Lamivudine,Efavirenz(d4T 40 mg twice daily,3TC 300 mg once daily,EFV 600 mg once daily)
Stavudine,Lamivudine,Lopinavir/Ritonavir(d4T 40m mg twice daily,3TC 300 mg once daily,r/LPV 400mg/100mg twice daily)