HPTN 083: A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), for Pre-Exposure Prophylaxis (PrEP) in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men
RELEVANCE: PrEP agents are needed that do not depend on daily or near-daily pill-taking. The development of alternative agents for PrEP, and/or more adherence-friendly schedules for currently available agents, could increase prevention choices and increase acceptability. Long-acting injectable agents have the potential to prevent HIV acquisition without relying on adherence to a daily oral regimen.
DESCRIPTION: Once randomized to one of two arms, participants will move through the steps below and followed for up to 4 and a half years:
Arm A – Daily oral CAB (30 mg tablets) and oral TDF/FTC placebo for five weeks
Arm B – Daily oral TDF/FTC (300 mg/200 mg fixed-dose combination tablets) and oral CAB placebo for five weeks
A participant that becomes HIV-infected during Step 1 of the study will permanently discontinue study product and will be terminated from the study, and referred for HIV-related care.
Arm A – CAB LA (600 mg as a single intramuscular [IM] injection at two time points 4 weeks apart and every 8 weeks thereafter) and daily oral TDF/FTC placebo.
Arm B – Daily oral TDF/FTC (300/200 mg fixed-dose combination tablets) and IM placebo at two time points 4 weeks apart and every 8 weeks thereafter (matching vehicle, identical volume as active injectable product in Arm A).
This step will continue until the required number of endpoints is reached.
A participant that becomes HIV-infected during Step 2 of the study will permanently discontinue study product, be placed on immediate suppressive ART, and be followed for 52 weeks after their last injection, after which their participation in the study will end and they will be transitioned to continued HIV-related care.
Both arms: Open-label daily oral TDF/FTC no later than 8 weeks after the last injection (in order to cover the pharmacokinetic (PK) tail for Arm A participants), for up to 48 weeks.
Participants will then transition to locally-available HIV prevention services, including services for PrEP, if available.
A participant with confirmed HIV infection during Step 3 will be followed at least for the duration of Step 3.
STATUS: Enrolling.For more information, call us toll free at 866-449-UCLA (8252) or email email@example.com.
HPTN 085: Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection
RELEVANCE: Preliminary data have shown antibodies to be a potential efficacious intervention in preventing HIV-1 infection.
DESCRIPTION: This study will evaluate the safety, tolerability, and efficacy of the VRC01 antibody in preventing HIV-1 infection in healthy adults at high risk of HIV infection. Participants will be men who have sex with men (MSM) and transgender people in the U.S., Peru and Brazil. An equal number of study participants will be randomized to receive VRC01 mAb by IV infusion at a dose of 10 mg/kg or 30 mg/kg every 8 weeks, or to receive control infusions every 8 weeks. All participants will receive the VRC01 antibody or placebo by intravenous infusion at Weeks 0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. For 3 days following each infusion, participants will be asked to record and report any symptoms to study researchers. In addition to the infusion visits, participants will attend study visits at Weeks 4, 8 + 5 days, 12, 20, 28, 36, 44, 52, 60, 68, 76, 80, 84, 88, and 92. All study visits will include blood collection and HIV testing and counseling. Select study visits will include a medical history review, physical exam, urine collection, pregnancy testing for participants capable of becoming pregnant, risk reduction counseling, and an interview/questionnaire.
STATUS: Currently Enrolling
Phase II Randomized Trial of Ibudilast For Methamphetamine Dependence
RELEVANCE: Despite numerous clinical trials, no medication has been approved to treat methamphetamine (MA) dependence. As a result, novel approaches to medication development for MA dependence, including linked medication development, where work in early safety trials can be used to inform the importance of continued (or not) assessment of novel or combination pharmacotherapies, is needed.
DESCRIPTION: Following up on the Phase I safety trial, the objective of this study is to test the safety and potential efficacy of ibudilast to treat methamphetamine dependence. The study hypotheses are that ibudilast will reduce methamphetamine use and increase treatment retention more than placebo among patients seeking treatment for methamphetamine dependence. As HIV infection is a common complication of methamphetamine dependence, half of the participants will be HIV positive and the study will assess whether ibudilast also improves HIV related outcomes (e.g. medication adherence, CD4 count, risk behaviors).
STATUS: Currently enrolling treatment seeking, methamphetamine-dependent persons. For more information, call us toll free at 866-449-UCLA (8252) or email firstname.lastname@example.org.
Using Social Media with Latino Men Who Have Sex with Men for HIV Testing and Linkage
RELEVANCE: In Los Angeles County Latinos comprise approximately 50% of all annually reported HIV infections, and Latino men who have sex with men (MSM) make up 85% of all HIV infections among Latinos. Identifying innovative ways of engaging Latino MSM in HIV testing, medical care, and prevention services has the potential to decrease HIV transmission among this population and improve health outcomes of those living with HIV.
DESCRIPTION: We propose to develop a culturally-tailored intervention to increase HIV testing and linkage to HIV medical care and prevention services among Latino MSM unaware of their HIV status. The intervention will consist of three interconnected and complementary components: 1) the use of social media, 2) the use of conditional cash transfers, and 3) linkage coordination to HIV medical care and/or prevention services. Social networking sites (SNS) with geo-based location services will be used to recruit high-risk Latino MSM. We hypothesize that our culturally-tailored social media program will result in identifying higher rates of HIV-positive Latino MSM, newly-identified HIV-positive Latino MSM accessing HIV medical care, and HIV-positive and high-risk HIV-negative Latino MSM accessing HIV prevention services compared to the local standard of care.
STATUS: This study has completed enrollment and data analysis is underway. For information on the results of this study, please contact the Principal Investigator, Dr. Ron Brooks, at email@example.com or by phone at 310-794-0619 ext. 226.
The LA PrEP Stories Project
RELEVANCE: Pre-Exposure Prophylaxis (PrEP) has the potential to reduce the number of new HIV infections among high-risk black and Latino men who have sex with men (BLMSM). However, issues related to the adoption of PrEP may negatively influence PrEP disclosure, diffusion, adherence and retention among BLMSM who adopt PrEP. The findings from this study will inform the development of intervention activities that seeks to prevent or moderate the negative social experiences associated with PrEP adoption and facilitate diffusion, adherence and retention to PrEP among minority MSM.
DESCRIPTION: The goal of this study is to learn about the experiences of BLMSM who have adopted PrEP and to assess its influence on PrEP disclosure, adherence and retention, and the diffusion of PrEP information to other potential BLMSM PrEP consumers. The specific aims of this study are: 1) to examine the experiences of BLMSM PrEP adopters; 2) to assess the extent and context of PrEP disclosure and dissemination of PrEP information by BLMSM PrEP users to other potential BLMSM PrEP consumers; and 3) to examine adherence and retention to PrEP, over time, among BLMSM PrEP adopters. BLMSM PrEP adopters will complete both a baseline and a 3-6-month follow-up interview. Follow-up interviews will assess changes in PrEP retention, adherence, disclosure and dissemination. Interviews with BLMSM non-PrEP adopters will determine the factors that may have influenced decisions to seek or not seek PrEP. Interviews will also be conducted with 20 medical providers to assess their perceptions of PrEP and PrEP stigma and concerns about the implementation of PrEP. The findings from this study will inform the development of intervention activities that seek to prevent or mitigate the negative social experiences associated with PrEP adoption and to optimize diffusion and retention to PrEP among minority MSM.
STATUS: Currently enrolling. For queries, please contact Omar Nieto at 323-461-3106 or email firstname.lastname@example.org
Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
DESCRIPTION: The primary objective of this double-blind, placebo-controlled, adaptive, randomized clinical trial is to evaluate the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder. Secondary outcomes will assess the safety of naltrexone plus bupropion and determine the efficacy of the combination pharmacotherapy on other substance use outcomes, on depression symptom scores, and on quality of life ratings. 370 individuals with moderate or severe methamphetamine use disorder will be randomly assigned to the active medication combination arm or the matching placebo arm. Participants will have visits twice weekly during the 12 week medication phase and complete follow-up visits in weeks 13 and 16.
STATUS: Enrolling – please call 310-709-1594 or email email@example.com
MSM and Substances Cohort at UCLA Linking Infections Noting Effects (MASCULINE), better known as the M Study
RELEVANCE: Stimulant use, especially among men who have sex with men (MSM) in Los Angeles County (LAC) is common. Stimulant drug use, particularly methamphetamine use, is a significant factor in the progression of HIV and STI among MSM in LAC. Non-white MSM are at greatest risk of HIV infection in the United States. Analyses of drug use are needed among diverse samples of MSM in order to understand the impact of drug use on the HIV epidemic over time and to address the effect of long-term drug use patterns on uptake and adherence to treatment and prevention of the disease.
DESCRIPTION: The goal of this project is to assemble a cohort of minority men who have sex with men (MMSM) who actively use substances and engage transmission risks. This will facilitate studies on interactions between substance use and HIV progression and/or transmission. This important cohort of MMSM will characterize: (i) effects substance use on risk behaviors, and network dynamics in exposed and infected MMSM on acquisition of HIV and other sexually transmitted infections (STIs: gonorrhea, Chlamydia, syphilis, Hepatitis C (HCV)); and (ii) the extent to which substance use in MMSM facilitates behaviors that transmit HIV compared to non-drug using MMSM.
STATUS: Currently enrolling at 2 sites. For more information, visit the study website at http://www.theMStudy.org.
Combating Craving with Contingency Management: Neuroplasticity and Methamphetamine Abuse in South Africa
RELEVANCE: Methamphetamine (MA) addiction is a global health problem with high prevalence and great social and health costs in the United States and in the Republic of South Africa and there is a strong need for development and implementation of effective MA treatment approaches.
DESCRIPTION: This study will enroll treatment-seeking, MA-dependent individuals into an 8-week contingency management (CM) program. At the beginning and end of the program, participants will participate in MRI scans while performing a working memory task and will complete a battery of select neurocognitive and psychological assays to address two specific aims: (1) to determine whether changes in neural function within frontostriatal circuitry (neural pathways that connect frontal lobe regions with the basal ganglia (striatum)) that mediate motor, cognitive, and behavioral functions within the brain from baseline to end of the 8-week CM program are associated with parallel changes in measures of cognitive control and impulsivity and with MA abstinence outcomes; (2) to determine whether structural changes in frontostriatal circuitry over the 8-week CM intervention correspond with neurocognitive, psychological and MA abstinence measures. Findings from this study will describe associations between functional and structural indices of brain areas that support working memory, cognitive control/inhibition; performance on select neurocognitive and psychological assessments; and associations between these with MA abstinence outcomes. Study activities and the neuroscience data generated will provide preliminary data for a larger, adequately powered study that will test ways to optimize behavioral therapies for treating stimulant use disorder.
STATUS: Currently enrolling at the University of Cape Town.
Phase II Randomized, Double-Blind Controlled Trial of HORIZANT® for Alcohol Use Disorder
RELEVANCE: Alcohol Use Disorder (AUD) affects 18 million Americans, and is linked to 80,000 deaths a year, presenting a staggering $224 billion dollar economic loss to society. Yet, there are only four medications approved by the FDA to treat AUD.
DESCRIPTION: The primary objective of this study is to compare the efficacy of HORIZANT® with a placebo on individuals with AUD. The secondary objectives are to assess other treatment benefits such as reduction in alcohol consumption, reduction in cravings of alcohol, mood, sleep quality, smoking quantity and frequency, and safety.
STATUS: Enrollment closed.