Last reviewed · How we verify
NCT02291809
REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
Phase 2 trial testing REMUNE in HIV/AIDS in 26 participants. Status unknown.
1 November 2019
Quick facts
| Lead sponsor | Immune Response BioPharma, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 1 November 2017 |
| Primary completion | 1 November 2019 |
| Estimated completion | 1 November 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- REMUNE — full drug profile →
Conditions studied
- HIV/AIDS — all drugs for HIV/AIDS →
Sponsor
Immune Response BioPharma, Inc. — full company profile →
Who can join
Adults 3 Months to 16, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The primary objective is to compare & evaluate between the treatment groups the changes in HIV viral load at Week 52
Time frame: 52 Weeks
The primary objective is to compare \& evaluate between the treatment groups the changes in HIV viral load (HIV RNA Viral Load) at Week 52 -
The primary objective is to compare & evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52
Time frame: 52 Weeks
The primary objective is to compare \& evaluate between the treatment groups the changes in WBC white blood cell counts at Week 52
Sponsor's own description
The primary objective is to compare \& evaluate between the treatment groups the changes in decline/reduction of HIV viral load \& increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Additional objectives include changes in CD4+ \& CD8+ T cell counts along with increased HIV immunity.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02291809
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07064785 — Video-Intervention to Inspire Treatment Adherence for Life for Adolescents · NA · recruiting
- NCT07074899 — Evaluation of a Multi-Component Intervention to Support HIV Testing and Linkage to Services Among MSM in Peru · NA · active not recruiting
Other Immune Response BioPharma, Inc. trials
Trials by the same sponsor.
- NCT02200718 — A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis · Phase 1 · unknown
- NCT02149706 — A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis · Phase 2 · unknown
- NCT02057159 — A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis · Phase 2, PHASE3 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02291809 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Immune Response BioPharma, Inc.
- Last refreshed: 22 February 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02291809.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing