Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-11001)
|ClinicalTrials.gov Identifier: NCT01335191|
Recruitment Status : Completed
First Posted : April 14, 2011
Results First Posted : February 15, 2013
Last Update Posted : February 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: TUTI-16 (1.0 mg) Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Clinical Study of TUTI-16 in Asymptomatic, HIV-1 Infected Subjects Effectively Controlled by Antiretroviral Therapy and the Effects on Viral Load During a Structured Treatment Interruption|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: TUTI-16 (1.0 mg)
Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
Biological: TUTI-16 (1.0 mg)
Two subcutaneous injections of TUTI-16 (1.0 mg) at Day 0 and Week 3.
Placebo Comparator: Placebo
Two subcutaneous injections of placebo at Day 0 and Week 3.
Two subcutaneous injections of Placebo at Day 0 and Week 3.
- Anti-Tat Antibody Titer [ Time Frame: 54 weeks ]ELISA based chemiluminescent assay to determine the anti-Tat antibody response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335191
|United States, New York|
|New York, New York, United States, 10019|
|Principal Investigator:||Mardik Donikyan, MD||Clinilabs, Inc.|