Press Releases and Announcements
On September 27, the ACTG announced the graduation of the novel polyclonal antibody therapy SAB-185 to the phase 3 study of ACTIV-2. Read more HERE.

This month, the ACTG announced the presentation of data for the monoclonal antibody combination therapy, BRII-196/BRII-198 from the ACTIV-2 study at the virtual IDWeek 2021 conference. Read more HERE.

In observance of National Latinx AIDS Awareness Day, HANC's New Investigators Working Group and the Latinx Caucus of the Legacy Project are hosting a webinar featuring Latinx HIV researchers, including ACTG investigators Drs. Moises Huaman and Amaya Perez-Brumer. You can register for the webinar HERE.
Assessing the Relationship Between Greater Muscle Fat and Lower Muscle Area and Inflammation and Immune Activation after Starting ART
Research has demonstrated that starting antiretroviral therapy (ART) is associated with an increase in skeletal muscle, though it tends to be quite fatty. A5260s explored whether the gains in skeletal muscle area or the amount of fattiness were associated with markers of inflammation and immune activation. Individuals living with HIV were randomized to start treatment with raltegravir, ritonavir-boosted atazanavir, or darunavir, in combination with tenofovir disoproxil fumarate/emtricitabine. This substudy included 222 participants and analyzed abdominal computed tomography (CT) scans at baseline and week 96 for muscle amount and fattiness and used previously measured markers of inflammation and immune activation. At baseline, greater muscle fat and lower muscle area were associated with higher inflammation and immune activation. From baseline to week 96, a greater increase in muscle fat and decrease in muscle area were associated with greater increases in inflammation and immune activation. Whether these muscle characteristics are the cause or the consequence of inflammation cannot be determined within this study. Future studies will need to explore the impact of these changes in muscle and inflammation on physical function and other complications, including cardiometabolic risk.

Kousari A, Moser C, Olefsky M, Brown TT, Currier JS, McComsey GA, Scherzinger A, Stein JH, Lake JE, Erlandson KM. Poorer Muscle Quality and Quantity with ART Initiation is Associated with Greater Inflammation and Immune Activation. J Acquir Immune Defic Syndr. 2021 Aug 5. doi: 10.1097/QAI.0000000000002776. Epub ahead of print. PMID: 34326283.

Exploring Cardiac Safety of Two Oral, Well-Tolerated Anti-TB Medicines when Taken Together
In 2012, bedaquiline and delamanid were the first new drugs approved for tuberculosis in more than 40 years. Both are oral and well-tolerated and intended to be used in patients who have drug-resistant TB. Historically, these individuals have had few treatment options and those regimens often included very toxic medicines. While bedaquiline and delamanid have a number of benefits, each drug modestly prolongs the QTc interval on the electrocardiogram (ECG). Because having a prolonged QTc can be a precursor to more serious cardiac toxicities (such as abnormal heart rhythms), the World Health Organization (WHO) recommended against using the two drugs together (as no one had carefully assessed the cardiac risk of doing so).

To address this knowledge gap, the randomized, controlled DELIBERATE trial (A5343), evaluated adding bedaquiline, delamanid, or both to background therapy in participants with multidrug resistant TB to accurately determine QTc effects of each drug alone versus together. ECGs were done frequently over the 24 weeks of treatment, in triplicate, and they were interpreted by an expert central reader. To be sure there were no adverse cardiac effects, early participants in the study were hospitalized and monitored carefully. A5343 found that adding delamanid to bedaquiline resulted in no more than additive QTc effects; no participants had grade 3 or 4 QTc events; and the study drugs were well-tolerated, including among people living with HIV. In exploratory analyses, eight-week sputum culture conversion was high in all groups and sustained in the combined treatment arm. These data suggest that co-administration of bedaquiline and delamanid among individuals with a normal QTc at baseline results in acceptable cardiac safety. Preliminary microbiology data were also encouraging in terms of treating drug-resistant TB. Based on these results, the WHO lifted their restriction on concurrent use of bedaquiline and delamanid, allowing them to be administered together among those patients who may need them the most.

Dooley, Kelly E., Susan L. Rosenkranz, Francesca Conradie, Laura Moran, Richard Hafner, Florian von Groote-Bidlingmaier, Javier R. Lama et al. "QT effects of bedaquiline, delamanid, or both in patients with rifampicin-resistant tuberculosis: a phase 2, open-label, randomised, controlled trial." The Lancet Infectious Diseases (2021).
Investigator Spotlight
Roberto Arduino, M.D., Houston AIDS Research Team CRS

Roberto C. Arduino, M.D., a professor of infectious diseases at McGovern Medical School at the University of Texas Health (UTHealth) Houston, has spent nearly four decades devoted to making a difference in the lives of people living with HIV and AIDS. 

Since 1997, he has led HIV research initiatives at UTHealth. He is the leader of the Houston AIDS Research Team (HART) at UTHealth, which serves as a Clinical Research Site within the ACTG. He is also a foundational member of Harris Health System’s Thomas Street Health Center – one of the first free-standing, full-service HIV clinics in the United States.

Dr. Arduino graduated with his Diploma of Honors from the Universidad de Buenos Aires, Facultad de Medicina in Buenos Aires, Argentina in December 1982. He came to Houston in 1990 for his fellowship at McGovern Medical School at UTHealth. He is passionate about training the next generation of physicians and researchers who will provide care for people living with HIV and in 1997 he established a fellowship program in HIV medicine that has since trained 28 physicians.

Dr. Arduino currently serves as the Vice-Chair of the Underrepresented Populations Committee (UPC), as a member of the Reservoirs, Remission, and Cure TSG, and as an investigator for A5354, "Early ART to Limit Infection and Establishment of Reservoir" and A5388, “bNAbs in Acute HIV.” in addition, since the onset of the pandemic, Dr. Arduino’s research team has participated in both industry and NIH-funded clinical research to develop therapeutics to treat and prevent COVID-19.

A fan of outdoor sports, Dr. Arduino spent years playing polo, windsurfing, roller hockey, and tennis. Recently, he has taken an interest in biking and CrossFit. As an opera fan, piano player, and cook, Dr. Arduino enjoys the lively music and culinary scenes that an international city like Houston has to offer.

Site Spotlight
MU-JHU Research Collaboration CRS - Kampala, Uganda

The MU-JHU Research Collaboration Research CRS has been part of the ACTG since 2016 under the Johns Hopkins University Kampala HIV Clinical Trial Unit and is currently conducting the PHOENIx study. The site’s team includes eight full-time ACTG staff and 50 part-time staff. While the full-time ACTG staff have worked together for about a year and a half, the part-time staff has worked together for more than 10 years on other NIH-supported studies. The Kampala team was very excited to take part in the first ACTG study at the site and the teamwork that went into getting the site ready was outstanding.
The site shared an interesting anecdote around treatment adherence in the study participants at their site. As background, when a household is recruited, they first have to enroll the Index case of MDR-TB. The National Referral Mulago Hospital TB ward provided monthly food, nutrition, and financial support to the Index case prior to PHOENIx. Through the analysis of a device used by the study to monitor daily study drug intake, it became clear that some participants were not taking their treatment. When asked about it, participants said that because they did not have food, they could not take the study drug. When these participants were brought to the clinic for further assessment, the study team learned that they had stopped taking the study drug and said that they did not have food in an effort to push the team to provide the food support that the index case received. The study team revisited the study consent form and explained that the Index case was being supported by a different program and that support was meant to facilitate treatment for MDR-TB.
“It was an interesting and interactive conversation with these study participants, since they opened up and explained how they had discussed among themselves and come to the conclusion that the study team was holding back the food supplementation, and also came up with a means to ensure these were provided,” said Hellen Kaganzi, MBChB. “The study team had an exhaustive counseling session with the household, and it was great to have them understand that we were not holding back anything. The participants voluntarily agreed to continue study participation, and continue taking the study drugs, and it was a very good experience on the effect of good ongoing counseling, to address any issues that may arise during study participation.”
The site reports that what has been most meaningful to them is the effect of the study intervention in protecting household members of the index case of MDR-TB. Site members have learned from home visits and interactions with the households that from the level of interactions among household members and their living facilities meant there was a high chance of the household members acquiring TB from the index case. It has added a great deal of meaning to their work to know that this study could provide helpful and lifesaving information that will eventually help similar household members.
Site staff is also proud to have been able to maintain 100 percent retention of study participants, despite the challenges posed by the COVID-19 pandemic.

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Upcoming Awareness Days:
- National Latinx AIDS Awareness Day - October 15

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