HIV-1 Infection Clinical Trial
Official title:
A Double-blind Placebo Controlled Immunogenicity Study of Vacc-4x + Lenalidomide Versus Vacc-4x With an Initial Open-label Dose Escalation Assessment of Lenalidomide in HIV-1-infected Subjects on Antiretroviral Therapy (ART).
During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced immunological response and ultimately immune deficiency. Vacc-4x is a peptide-based HIV immunotherapy and the primary objective is to strengthen the immune system's response to HIV p24. By adding Lenalidomide, an immunomodulatory agent, as a supporting drug, it is anticipated that the effect of Vacc-4x might be enhanced.
Human immunodeficiency virus (HIV) infects the CD4 subset of T-cells that are critical for
initiating immune responses to infection. The level of CD4 cells in the blood is a marker of
a patient's immunological status. The number of CD4 cells decreases in the course of the HIV
infection and results in a reduced immunological response and eventually immune deficiency.
Vacc-4x is one of the few peptide-based therapeutic vaccines tested, and consists of four,
slightly modified HIV Gag p24 consensus peptides. Vacc-4x was first tested by intradermal
injections using GM-CSF as adjuvant. A recent multinational placebo-controlled study found
improvement of vaccine-specific T cell immunity and decrease in viral loads (presented at
the AIDS vaccine 2011 conference, Bangkok).
Lenalidomide (CC-5013) is a substance in the class of immunomodulatory agents. The
lenalidomide mechanism of action includes anti-neoplastic, pro-erythropoietic, and
immunomodulatory properties. Lenalidomide inhibits proliferation of certain hematopoietic
tumor cells, enhances T cell- and Natural Killer (NK) cell-mediated immunity and increases
the number of NK T cells.
The anti-HIV p24 immune response resulting from Vacc-4x immunization could in combination
with ART potentially improve immune reconstitution in patients who have not fully regained a
healthy CD4 level (> 600 x106/L). Adding the immunomodulatory agent Lenalidomide (CC-5013)
to Vacc-4x immunization could enhance the immune response to Vacc-4x and further strengthen
immune reconstitution.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03188523 -
Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)
|
Phase 1 | |
| Recruiting |
NCT06185452 -
Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine
|
Phase 4 | |
| Recruiting |
NCT02881320 -
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
|
Phase 2/Phase 3 | |
| Completed |
NCT02513771 -
Sitagliptin for Reducing Inflammation and Immune Activation
|
Phase 2 | |
| Completed |
NCT02542852 -
A Study of a Nucleoside Sparing Regimen in HIV-1 Infected Patients With Detectable Viremia
|
Phase 2 | |
| Terminated |
NCT02732457 -
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
|
||
| Completed |
NCT02057796 -
Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3
|
Phase 4 | |
| Completed |
NCT01989910 -
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
|
Phase 4 | |
| Completed |
NCT01627678 -
Immunotherapy With Vacc-C5 With Adjuvant GM-CSF or Alhydrogel in HIV-1-infected Subjects on ART
|
Phase 1/Phase 2 | |
| Completed |
NCT01466595 -
Rifaximin as a Modulator of Microbial Translocation and Immune Activation
|
Phase 2 | |
| Completed |
NCT01348308 -
Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients
|
Phase 3 | |
| Completed |
NCT01403051 -
High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
|
Phase 2 | |
| Completed |
NCT01511809 -
Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression
|
Phase 3 | |
| Completed |
NCT01019551 -
Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients
|
Phase 2 | |
| Terminated |
NCT01130376 -
Novel Interventions in HIV-1 Infection
|
Phase 1 | |
| Completed |
NCT00323687 -
SONETT: Switch Study to Once Daily HIV Treatment Regimen With Truvada
|
Phase 4 | |
| Completed |
NCT04003103 -
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
|
Phase 2 | |
| Completed |
NCT02527096 -
A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple Highly Active Antiretroviral Therapy (HAART) (ANRS 167 Lamidol)
|
Phase 2 | |
| Active, not recruiting |
NCT04776252 -
Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)
|
Phase 3 | |
| Completed |
NCT02174159 -
Evaluation of Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Ulonivirine (MK-8507) in Human Immunodeficiency Virus (HIV-1)-Infected Participants (MK-8507-003)
|
Phase 1 |