drugset / Trial / NCT00885664
Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purposes of this study are: 1. To understand whether the use of HIV therapy in persons with more advanced HIV disease results in greater side effects. 2. To determine whether these side effects can be related to greater activation of the immune system.
Timeline
- Start
- 2005-10
- Primary completion
- 2009-09
- Completion
- 2010-03
Outcome
Missed primary endpoint
registry analysis (superiority test); CD4<100 vs CD4>/=100; p = 0.45; Wilcoxon (Mann-Whitney) NCT00885664 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lopinavir | Other / unclassified | 400 mg | — |
| Subject | Ritonavir | Other / unclassified | 100 mg | — |
| Subject | Tenofovir | Small molecule | — | — |
| Subject | emtricitabine | Other / unclassified | — | — |