A Year in Review

Over the past year, the AIDS Clinical Trials Group (ACTG) Network has experienced continued growth as evidenced by the completion of four studies, the completed accrual of seven studies and the opening to enrollment of five new studies. This progress is vital to the Network’s continued success in achieving our mission of reducing the burden of disease due to HIV/AIDS, tuberculosis and viral hepatitis.  Recently, at the 2015 Annual ACTG Network Meeting, Dr. Daniel Kuritzkes, Principal Investigator and Chair of the ACTG Executive Committee presented the Year in Review. 

Studies Completed Follow-Up

  • Protocol A5245 (HPTN 052): When to Start ART Outside the US was closed to follow-up on May 3, 2015 following 312 weeks on study. 

  • Protocol A5273: Study of Options for Second-Line Effective Combination Therapy (SELECT) was closed to follow-up on October 29, 2014 following 96 weeks on study. 

  • Protocol A5294: Boceprevir, Interferon, Ribavirin to Treat HCV/HIV Co-infected Subjects (BIRTH) was closed to follow-up on April 15, 2015 following 76 weeks on study. 

  • Protocol A5295: Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in HIV-Infected and HIV-Uninfected Pulmonary Tuberculosis Suspects was closed to follow-up on February 18, 2015 following 12 weeks on study.

Studies Completed Accrual

  • Protocol A5274: Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens (REMEMBER) was closed to further accrual on July 07, 2015 with a total of 786 study participants. 

  • Protocol A5279: Short-Course Rifapentine/Isoniazid for Treatment of Latent TB in HIV-Infected Individuals was closed to further accrual on November 14, 2014 with a total of 3,000 study participants.

  • Protocol A5305: Novel Exploration of Therapeutics for Pre-Exposure Prophylaxis (PREP) was closed to further accrual on December 1, 2014 with a total of 410 study participants. 

  • Protocol A5308: FTC/RPV/TDF on CD4 Cell Count, Inflammatory Biomarkers, T- Cell Activation and Viral Reservoir was closed to accrual on December 31, 2014 with a total of 38 study participants. 

  • Protocol A5322: Long-term Follow-up of Older HIV-infected Adults: Addressing Aging, HIV Infection & Inflammation was closed to accrual on July 31, 2014 with a total of 1,040 study participants.  

  • Protocol A5331: Modulation of Immune Activation by Aspirin was closed to accrual on June 30, 2015 with a total of 121 study participants.  

  • Protocol 1077HS: HAART Standard Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere) was closed to accrual on November 30, 2014 with a total of 829 study participants. 

Studies Open to Accrual

  • Protocol A5307: Essentiality of Isoniazid in Tuberculosis Therapy began accruing study participants on June 30, 2015 and is currently enrolling at two international sites. 

  • Protocol A5312: High-Dose Isoniazid Among Adult Patients with Different Genetic Variants of INH-Resistant TB began accruing study participants on August 13, 2014 and is currently enrolling at one international site. 

  • Protocol A5316: Evaluating Pharmacokinetic Interactions with Vaginal Ring Contraceptives and ART began accruing study participants on December 30, 2014 and is currently enrolling at 25 sites, both domestic and international. 

  • Protocol A5331: Modulation of Immune Activation by Aspirin began accruing study participants on March 9, 2015 and is currently enrolling at 14 domestic sites. 

  • Protocol A5342: Impact of VRC01 on HIV Persistence began accruing study participants on May 27, 2015 and is currently enrolling at 18 domestic sites.    

From May 2014 to April 2015, the ACTG Network enrolled a total of 2902 study participants across all studies.  To break this number down further, 2400 participants were enrolled in interventional trials, and 502 participants were enrolled in observational studies.  To put the geographical expanse of these studies into perspective, it should be noted that 1865 participants were enrolled at international sites and 997 participants were enrolled at domestic sites.  An additional 40 study participants were enrolled at non-ACTG sites.  These impressive numbers attest to the hard work and diligence the ACTG Network has undertaken in its effort to reduce the burden of disease due to HIV/AIDS, tuberculosis and viral hepatitis.