Adaptavir (DAPTA) Clinical Trials

Size	Price	Qty
5mg	USD 170
25mg	USD 507

Clinical Trials

Multiple Phase 2 clinical trials, sponsored exclusively by Rapid Laboratories Inc., are currently evaluating Adaptavir for the treatment of HIV infections. These studies investigate the compound's safety and efficacy in eliminating treatment-resistant infectious virus within the peripheral blood mononuclear cell reservoir, although their recruitment status remains unknown. Overall, this clinical effort reflects a focused approach to target persistent viral reservoirs and enhance therapeutic strategies for managing HIV.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00951743	UNKNOWN	HIV Infections	Rapid Laboratories Inc.	2009-07	PHASE2
NCT00951743	Unknown status	HIV Infections	Rapid Laboratories Inc.	2009-07	Phase 2

(data from https://clinicaltrials.gov, updated on 2009-08-11)

Check the Adaptavir (DAPTA) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Adaptavir functions as a potent and selective CCR5 antagonist, potently inhibiting CD4-dependent binding of viral gp120 isolates Bal and CM235 with IC50 values of 0.06 nM and 0.32 nM, respectively, to prevent viral membrane fusion and host cell entry. By disrupting CCR5-mediated entry pathways and preventing host cellular infection, the compound suppresses viral propagation, which is clinically relevant for eliminating treatment-resistant viral reservoirs in patients with HIV infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).