Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects (THYMON-11001)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|