Increasing HAART-Induced Immune Restoration With Cyclosporine

Phase 2 Completed 40 enrolled National Institute of Allergy and Infectious Diseases (NIAID)

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to see if cyclosporine, taken when a patient begins highly active antiretroviral therapy (HAART), increases the number of CD4 T-cells (blood cells that fight infection) in a patient's blood. This study also will explore the safety of briefly giving cyclosporine to patients starting HAART.

Timeline

Start: —
Primary completion: —
Completion: 2006-12

Publications

Lederman MM, Smeaton L, Smith KY, Rodriguez B, Pu M, Wang H, Sevin A, Tebas P, Sieg SF, Medvik K, Margolis DM, Pollard R, Ertl HC, Valdez H. Cyclosporin A provides no sustained immunologic benefit to persons with chronic HIV-1 infection starting suppressive antiretroviral therapy: results of a randomized, controlled trial of the AIDS Clinical Trials Group A5138. J Infect Dis. 2006 Dec 15;194(12):1677-85. doi: 10.1086/509261. Epub 2006 Nov 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclosporine	Peptide	—	—
Background	Abacavir	Other / unclassified	—	—
Background	Efavirenz	Other / unclassified	—	—
Background	Hepatitis A Vaccine (Inactivated)	Vaccine	—	—
Background	Lamivudine	Other / unclassified	—	—
Background	Pneumococcal Conjugate Vaccine, Heptavalent	Vaccine	—	—
Background	Rabies vaccine	Vaccine	—	—
Background	Zidovudine	Small molecule	—	—

Increasing HAART-Induced Immune Restoration With Cyclosporine

Summary

Timeline

Publications

Drugs

Indications