RV 217 (ECHO) is an international observational study tracking up to 500 HIV-uninfected volunteers, with a target of enrolling 150 HIV-infected individuals during the acute phase of HIV infection (AHI). Subjects are enrolled from populations at high risk for infection. Study sites are located in:
- Bangkok, Thailand
- Kericho, Kenya
- Kampala, Uganda
- Mbeya, Tanzania
RV 254 (SEARCH 010) is an observational study in Bangkok, Thailand. The study team screens 30,000 subjects each year with a target of capturing 30 AHI subjects per year. Subjects are enrolled at the Anonymous Clinic of the Thai Red Cross AIDS Research Centre, and undergo full neurological and neuropsychological evaluation at baseline and annually. Blood, plasma, and CSF specimens are captured and stored for virological and immunological assays, and subjects also undergo MRI.
RV 304 (SEARCH 013) is operated in Bangkok, Thailand, where study staff perform gut biopsies and lumbar punctures (LP) on 100 HIV-uninfected and 100 HIV-infected subjects. This study will provide important control data for comparison with study RV 254 (SEARCH 010) above. HIV-infected subjects are recruited for this study from RV 254 (SEARCH 010).
RV 329 (AFRICOS) is an observational study operating at five sites in Africa, with the goal of enrolling 3,600 HIV-infected and 600 HIV-uninfected subjects. Study sites are in Kenya, Nigeria, Tanzania, and Uganda. The primary objective of this study is to assess the impact of clinical practices, biological factors, and socio-behavioral issues on HIV infection and disease progression over time in an African context.
RV 397 is a treatment interruption study that will test the efficacy of vaccine administration during analytical treatment interruption (ATI). The study will enroll 24 HIV-infected subjects who initiated antiretroviral therapy (ART) within the first few weeks of infection and who have successfully suppressed viral load with ART for at least 2 years. The study site is in Bangkok, Thailand. This study will recruit from RV 254 (SEARCH 010). As in all interruption studies, subjects will be monitored frequently and put back on ART if rebound is detected.
RV 398 is a protocol designed to study the co-administration of a vaccine and ART. Each arm of this study will have 8 subjects for a total sample size of 24 subjects. Subjects are recruited from RV 217 (ECHO). Study sites are located in:
- Bangkok, Thailand
- Kericho, Kenya
- Kampala, Uganda
- Mbeya, Tanzania
RV 405 (SEARCH 023) is a treatment interruption study that will administer a vaccine and a mosaic during ATI. Subjects will be enrolled in Bangkok, Thailand from RV 254 (SEARCH 010), and only subjects who had ART prescribed for 2 or more years previously will be eligible. A total of 36 participants will be enrolled in a 2:1 ratio of vaccine/mosaic (n=24) to placebo (n=12). As in all interruption studies, subjects will be monitored frequently and put back on ART if rebound is detected.
RV 408 (SEARCH 018) will examine the nervous system impact of administration of an adjunctive anti-inflammatory therapy with ART during acute HIV infection. A total of 21 subjects will be enrolled, with 14 receiving ART plus the adjunctive treatment, and 7 receiving ART only. This study will occur in Bangkok, Thailand and subjects will be recruited from RV 254 (SEARCH 010).
RV 411 (SEARCH 022) is a treatment interruption study that tracks ATI on subjects who have had ART for at least 2 years. An initial 8 subjects will be assessed 12 weeks after ATI to determine the safety of the study. If at least one of these subjects maintains viral suppression after 12 weeks, an additional 7 subjects will be recruited for a total sample size of 15. This study will take place in Bangkok, Thailand and will recruit from RV 254 (SEARCH 010). As in all interruption studies, subjects will be monitored frequently and put back on ART if rebound is detected.
RV 412 (SEARCH 025) is a surveillance study for subjects who have completed an interruption study. This study will be an open cohort without restriction on sample size, though enrollment is not expected to exceed 500 subjects. The study site will be Bangkok, Thailand and the study will recruit from the interruption studies listed above. Subjects not on ART at study start will be monitored closely and put back on ART if rebound is detected.
RV 419 is currently being designed to capture normative data in Africa for various tissues.
RV 424 (SEARCH 026, Neuro substudy of RV 409/SEARCH 019) is a treatment Interruption study designed to investigate the nervous system effects of co-administration of a histone deacetylase (HDAC) inhibitor combined with other medications and ART, followed by ATI. The total sample size will be 15 with a 2:1 ratio of subjects receiving ART and the HDAC inhibitor intervention to subjects receiving ART only. The study site will be Bangkok, Thailand and will recruit subjects who have been on ART for at least 42 weeks from RV 254 (SEARCH 010). As in all interruption studies, subjects will be monitored frequently and put back on ART if rebound is detected.
Sexual Network Substudy was conceived to investigate the role of sexual networks in influencing HIV risk among MSM in Thailand, since HIV risk is based not solely on personal risk behaviors but also risk behaviors of those in one's sexual network. An expected sample size of 150 HIV-infected MSM enrolled in RV 254 (SEARCH 010) in Bangkok, Thailand will undergo both egocentric and sociometric network analyses. This study aims to describe structural and compositional characteristics of sexual networks of Thai MSM with acute HIV infection as well as changes in sexual networks over time.
Decision-making Substudy will be conducted in coordination with the four HIV clinical trials above, which offer unique opportunities to learn from both participants and decliners about decision-making and expectations of potential risks and benefits. After completing a 20-minute pre-decision survey, approximately 60 individuals who decide to enrolled in a clinical study and 25 individuals who elect not to enroll will complete three 60-minute interviews throughout the the course of the clinical trial. The knowledge gained will inform participant engagement, the informed consent process, and design of future HIV cure studies.
Modeling Neurologic Involvement in Nonhuman Primates is being conducted at the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Bangkok, Thailand in their US-Army run, AAALAC-accredited vivarium and associated research laboratories. Hybrid simian-human immunodeficiency virus is being used as a clinically relevant, non-accelerated model of HIV disease prior to end-stage encephalitis to understand the pathogenesis of early neurologic involvement in the CNS, and to study the effect of ART and future therapeutic interventions on the brain, CSF and on cognitive and motor function.