NNRTI/PI Toxicity Switch to Darunavir Study
Summary
The purpose of the study is to examine the effects of switching from antiretroviral combinations that includes efavirenz (Sustiva®), lopinavir/ritonavir (Kaletra®) or atazanavir/ritonavir (Reyataz®/Norvir®) in individuals experiencing side effects from one of these agents, and replacing these with a new HIV medication called Darunavir also given with ritonavir (Norvir®). The study will primarily investigate the effect of change in medication on the subjects viral load (the levels of the HIV virus in the blood), on immunological parameters (CD4 count) and on other safety parameters (such as cholesterol) and also quality of life.
Timeline
- Start
- 2008-10
- Primary completion
- 2010-07
- Completion
- 2010-07
Outcome
Outcome not reported
Stopped (Enrollment): “Difficulties in recruitment due to a change in the nature of practice.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Darunavir | Small molecule | 800 mg | Oral |
| Comparator | Ritonavir | Other / unclassified | 100 mg | Oral |