AIDS Clinical Trials Group Network

Investigator: Francesca Aweeka, PharmD
Sponsor: Brigham and Women's Hospital

Location(s): United States


The ACTG Network Laboratory (ACTG NL) provides centralized laboratory services for HIV-1 RNA quantification and viral sequencing for drug resistance, support for U.S. specimen-processing laboratories, support for international service laboratories (safety testing, CD4+ cell count, and TB diagnostics), and support for the Oral HIV/AIDS Research Alliance (OHARA; funded by the National Institute for Dental and Cranial Research [NIDCR]). Through the coordinating efforts of the HIV/AIDS Network Coordinating Center (HANC), the ACTG NL participates in a plan to harmonize laboratory testing across networks to improve efficiency and collaboration through an established Total Quality Management (TQM) program that emphasizes good clinical laboratory practices (GCLP) and real-time monitoring of proficiency testing (PT) results.

The ACTG NL consists of Core Laboratory groups in immunology, pharmacology, and virology. Each Core Laboratory Group is comprised of several Specialty Laboratories that provide a broad range of assays and services required to conduct the scientific agenda of the ACTG and to complement laboratory services, and where appropriate, with that of other DAIDS-sponsored HIV/AIDS clinical trials networks.

The Pharmacology Laboratory infrastructure consists of Pharmacology Specialty Laboratories (PSLs). The PSLs carry out protocol-required pharmacologic assays and develop and validate new assays such as sensitive and specific liquid chromatography/mass spectrometry measuring tenofovir and emtricitabine and a high-performance liquid chromatography/tandem mass spectroscopy for measuring artemether, to name a few. The PSLs participate in research on bioavailability, drug-drug interaction, gender specific analyses, and have determined pharmacokinetic parameters for several antiretroviral drugs.