Specialty Laboratories - Immunology Specialty Laboratories - Pharmacology Specialty Laboratories - International Pharmacology Specialty Laboratories - Virology Specialty Laboratories - Genotyping Specialty Laboratories - Tuberculosis International Specialty and Regional Testing Laboratories

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.

Specialty Laboratories

The ACTG provides access to laboratories with state-of-the-art expertise in specialized assay development and application. The ACTG funds these core laboratories and through them centralizes the immunology, pharmacology and virology research specimen analysis.

The core laboratory approach affords uniformity of data, efficiency with reduced cost, streamlined specimen tracking, quality assurance, and rapid incorporation of novel techniques. In addition to routine laboratory testing, the Specialty Laboratories are involved with the development of innovative assays and methodologies.

The ACTG NL provides both standard and specialized laboratory support for the specific aims under each of the five major research priorities identified by the ACTG Network leadership which include:

  1. Translational Research and Drug Development
  2. Optimization of Clinical Management, including Co-Morbidities
  3. Vaccine Research and Development with the emphasis on immunotherapeutics (in collaboration with the HVTN)
  4. Prevention of Mother-to-Child Transmission of HIV-1, with the emphasis on the treatment of non-pregnant women (in collaboration with the IMPAACT Network)
  5. Prevention of HIV-1 Infection, with the emphasis on identifying and treating primary/early infection (in collaboration with the HPTN).

Immunology Specialty Laboratories

The Immunology Laboratory infrastructure consists of Immunology Specialty Laboratories (ISLs) that carry out protocol-required immunologic assays such as cytokine (IL-2, TNF) quantitation, lymphocyte proliferation, HIV-1 specific CTL, NK assays, and assessment of immune activation markers. The ISLs also develop and validate new methodologies such as measurement of translocated bacterial DNA, point of care CD4 testing, and they perform multisite comparisons of immunologic assays for detecting immune responses in HIV immunotherapeutic studies.

Case Western Reserve University School of Medicine Michael Lederman
Rush-Presbyterian-St. Luke's Medical Center Alan Landay
University of Pittsburgh Charles Rinaldo Jr.

Pharmacology Specialty Laboratories

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.

SUNY at Buffalo Gene Morse
University of Alabama, Birmingham Edward P. Acosta
University of California, San Francisco Francesca Aweeka
University of Nebraska Courtney V. Fletcher

International Pharmacology Specialty Laboratories

The international specialty pharmacology laboratories (IPSL) support the ACTG scientific agenda in the areas of international HIV/AIDS, TB, Malaria and viral hepatitis pharmacology research through original research and participation in current ACTG protocols. Two awards were made in 2011 for an IPSL (Cape Town) and a developmental IPSL (University of Zimbabwe, Harare).

University of Cape Town Gary Maartens
University of Zimbabwe Charles Maponga

Virology Specialty Laboratories

The Virology Laboratory infrastructure consists of Virology Specialty Laboratories (VSLs). The VSLs carry out protocol-required virologic assays and develop and standardize new virologic assays for future application to ACTG clinical trials. These laboratories have developed new assays such as validation of a stratified squamous epithelial model used to show that HIV-1 fails to trigger innate immune factor synthesis in differential oral epithelium. Research conducted in the area of virology has included; antiretroviral therapy and HIV-1 drug resistance, the importance of minor drug-resistant HIV-1 variants, coreceptor usage, viral fitness, interactions among HIV-1 and other viruses, HIV pathogenesis and hepatitis, and compartmentalization of HIV-1 and response therapy.

Harvard University Daniel R. Kuritzkes
University of Pittsburgh John Mellors
University of Washington Robert W. Coombs

Genotyping Specialty Laboratories

Non-U.S. genotyping laboratories have provided both protocol support for resistance genotyping and insight into local antiretroviral drug resistance. Investigator- initiated research continues into the validation and design of affordable HIV RNA and CD4+ diagnostic assays for implementation in resource-limited settings, and studies into the significance of ART resistance in their respective geographic regions.

Y. R. Gaitonde Centre for AIDS Research and Education, Voluntary Health Services Chennai (YRG CARE Medical Center) Pachamuthu Balakrishnan
The Fundação Oswaldo Cruz Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FIOCRUZ) Beatriz Grinsztejn
Wits HIV Clinical Research Site (Wits) Wendy Stevens

Tuberculosis International Specialty and Regional Testing Laboratories

The ACTG Tuberculosis (TB) Laboratory infrastructure is comprised of four Regional TB Diagnostic Laboratories (RTBDL) funded by the ACTG network. These laboratories are experienced and equipped to run the full spectrum of TB diagnostic assays from staining to molecular assays such as HAIN and GeneXpert, along with any ACTG protocol TB testing that is required. In addition to these activities, under the direction of the RTBDL oversight committee, the RTBDLs provide assay training, develop and assist with the validation of novel TB assays.

Regional TB Diagnostic Laboratories

BARC SA and Lancet Laboratory Consortium Regional TB Diagnostic Laboratory Dr. Carole Wallis
Uganda-Case Western Reserve University Research Moses Joloba
YRG CARE Regional TB Diagnostic Laboratory Vignesh Ramachandran

Tuberculosis International Regional Diagnostic Testing Laboratories Oversight Committee (RTBDL OC)

The RTBDL OC is comprised of the Regional TB Diagnostic Laboratory (RTBDL) Directors (or designee) and invited members from other ACTG or IMPAACT affiliated TB laboratories. The RTBDL OC function is to coordinate the RTBDL and TB laboratories to ensure they are ready to perform the testing for these protocols.  This is done through:

  • Assay development, training and assay validation with the laboratory-specific requirements of the TB TSG;
  • Ensuring Quality Assurance Programs (NHLS/WITS and MRI Global) are available to support the assays that are required by the protocols thereby providing quality management improvements for our TB-related EQA programs;
  • Ensure a close working relationship with the ACTG protocol mycobacteriologists ensuring the appropriate TB laboratory expertise for all ACTG TB protocols.  The protocol mycobacteriologist in turn works closely with the assigned Laboratory Technologist to implement TB-specific protocol testing.