NCT00342355

Antiretroviral Therapy for Advanced HIV Disease in South Africa

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 and/or CD4+ Cell Counts Less Than 200 Cells/MicroL

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,771 (actual)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Zidovudine	600 mg once daily
DRUG	Stavudine	40 mg once daily
DRUG	Didanosine	\<60 kg/125 mg twice daily or \>60kg/200 mg twice daily
DRUG	Lamivudine	300 mg once daily
DRUG	Efavirenz	600 mg once daily
DRUG	Lopinavir/Ritonavir	r/LPV 400mg/100mg twice daily

Timeline

• Start date: 2004-01-01
• Primary completion: 2008-03-01
• Completion: 2008-08-01
• First posted: 2006-06-21
• Last updated: 2013-05-21
• Results posted: 2013-04-16

Locations

7 sites across 1 country: South Africa