At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
ART Intensification +1 moredrug
Likely dose
ART Intensification 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
International, Multicenter, Randomized, Non-comparative Controlled Study of Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients With Long-term Viral Suppression
In Brief
A Phase 2 clinical trial evaluating ART Intensification and Immunomodulation for HIV-1 Infection. Completed, enrolled 29 participants across 5 sites in 4 countries.
Detailed Summary
Viral eradication in selected HIV-infected patients is possible with intensive antiretroviral therapy plus immunomodulation
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesFrance, Italy, Spain, United Kingdom
CollaboratorsCytheris SA, Merck Sharp & Dohme LLC, Pfizer
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2009
Enrollment StartSep 2010
Primary CompletionJul 2012
Study CompletionFeb 2013
TodayJul 2026
First PostedNov 25, 2009
Enrollment StartSep 1, 2010
Primary CompletionJul 1, 2012
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.6 years ago
Interventions
ART Intensificationdrug
Current ART regimen plus raltegravir and maraviroc Raltegravir : 400 mg PO BID for 56 weeks Maraviroc : 150, 300 or 600 mg PO BID depending on concomitant ART treatment, for 56 weeks
Immunomodulationbiological
Starting at Week 8, 1 cycle of 3 injections (1 per week) of recombinant human Interleukin-7 (r-hIL-7 / CYT107) at a 20 µg/kg dose.