Site Details
LOCATION
Asociacion Civil Impacta Salud y Educacion-Barranco Clinical Research Site
Av. Almirante Miguel Grau 1010
Barranco, Lima, 04.
SiteType
CRS
Site Trials
Treatment Experienced
ACTG A5424: Menopausal Hormone Therapy for Women Living with HIV (HoT)
Menopausal hormone therapy (MHT) is considered the most effective therapy for vasomotor symptoms (VMS; also known as hot flashes and night sweats), and the most appropriate choice to prevent bone loss during menopause. However, the safety and effectiveness of menopausal MHT has not specifically been studied in women living with HIV (WLWH).
“HoT” is a trial of MHT (transdermal estradiol with or without oral progesterone) versus placebo for WLWH in the late menopausal transition or early postmenopause with moderate to severe VMS. Study participants will record their VMS in a daily diary for 3 to 5 weeks. Those meeting VMS eligibility criteria will then be randomized to receive either study medication (MHT) or placebo and record their VMS in a daily diary for 12 weeks.
Treatment Experienced
Active, Not Recruiting
ACTG A5402: An Open-Label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD with Mild Neurocognitive Disorder (MND) in Persons with HIV: COPE
A5402 is a phase II, open-label, randomized clinical trial comparing the efficacy and safety of two medications (pramipexole versus escitalopram) for treating major depressive disorder (MDD), including with mild neurocognitive disorder (MND), in persons with HIV (PWH) over 24 weeks. The study will also look at any effect on activities of daily living.
Tuberculosis
A5409: A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (RAD-TB)
The standard of care (SOC) treatment of tuberculosis (TB) was developed over 40 years ago, and the treatment is long (6 months) and hard. In many settings, the medicine does not work well because people stop taking it or miss doses, which leads to TB returning. For some people, the SOC treatment can cause negative side effects.
This study will evaluate new medication regimens for the treatment of TB. This study is adaptive, which means, as new medication regimens are identified for the treatment of TB, some of them will be selected for testing in this study. Therefore, there may be different drug regimens being used as part of the study at different times.
Tuberculosis
Active, Not Recruiting
A5397/HVTN 603:A Phase 2a/2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants with Rifampicin-Susceptible Pulmonary TB
Effective tuberculosis (TB) treatment is available and saves millions of lives, but it has not had a significant impact on the global TB epidemic. The treatment requires strict adherence to taking the medicine on schedule, and if it isn’t taken as directed people can relapse before they complete treatment. TB can recur in up to 8% of people who successfully complete TB treatment. Having an effective TB vaccine to prevent TB infection and control TB disease is essential to eliminate TB globally.
A5397/HVTN 603 will give participants 2 injections of a study vaccine called ID93+GLA-SE or a placebo at different times after they have started taking TB treatment. The researchers will compare responses in people who get the study vaccine to people who get the placebo. This study will enroll both people with and without HIV. It is the first to test ID93 + GLA-SE in people living with HIV (PLWH).
Treatment Naïve
A5388: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission
Scientists are looking for ways to minimize the distribution of HIV-1 in the body, especially where anti-HIV medications (ART) are unable to reach. Starting ART as soon as possible following a diagnosis of Acute HIV Infection (AHI) has been shown to better preserve the immune system. Broadly neutralizing antibodies (bNAbs), when administered with ART, also have the potential to prevent the HIV virus from being able to reproduce.
This is a randomized, placebo-controlled research study that will enroll adults with recently diagnosed AHI. All participants will begin ART at entry and receive a single dose of two bNAbs (VRC07-523LS and PGT121.414.LS) or placebos. Everyone will be followed for about 1 year after starting ART, then stop ART for up to 2.5 years, then be followed for 1 year after restarting ART.
Treatment Experienced
Closed to accrual
A5403: Giving Standardized Estradiol Therapy In Transgender Women to Research Interactions with HIV Therapy: the GET IT RIgHT Study
Transgender women (TW) are the fastest-growing group of people with HIV. Historically, TW have had few opportunities to participate in research, and often experience barriers to engaging in care. More research is needed to help providers when it comes to choosing HIV medications in TW on Feminizing Hormone Therapy (FHT). This is an open-label, non-randomized trial of adult TW on three types of HIV medications who will receive estradiol for FHT for 48 weeks.
HIV Cure
Closed to accrual
A5341s: Size and Decay of HIV-1 Reservoirs in Tissues and Cerebrospinal Fluid in Participants on Long-Term Antiretroviral Therapy: A substudy of the ACTG HIV Reservoirs Cohort (AHRC) Study
Longitudinal Sampling Substudy of A5321 is collecting information from measures of different HIV reservoirs, including where HIV can be found, whether different reservoirs have different amounts of HIV, the best way is to measure the amount of HIV in different reservoirs, and whether the amount of HIV found in one reservoir says anything about the amount of HIV in other reservoirs.
See More Info on A5321 to learn more.
HIV Cure
Treatment Experienced
A5321: Decay of HIV-1 Reservoirs in Participants on Long-Term Antiretroviral Therapy: The ACTG HIV Reservoirs Cohort (AHRC) Study
AHRC (pronounced “ARC”) is a study of differences and changes over time in HIV reservoirs (groups of HIV-infected cells that “hide” from anti-HIV medications). This study enrolls people into one of six groups, based on their different HIV treatment histories. The current version of this study is only enrolling for Group 6, which will include people who acquired or are suspected to have acquired HIV while taking long-acting cabotegravir (LA CAB) for pre-exposure prophylaxis (PrEP).
HIV comorbidities and complications
Closed to accrual
A5332: REPRIEVE Trial
In this study, people between the ages of 40 and 75 with HIV will be randomized (like flipping a coin) to take the pill pitavastatin OR a placebo (non-active pill) to see if pitavastatin can help prevent heart disease and death in people who are taking HIV medication. You will not know if you are taking pitavastatin or placebo. The REPRIEVE trial will enroll about 7500 people from several countries.
Tuberculosis
Closed to accrual
A5300B/I2003B: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB)
This trial is in household contacts (HHC) at high risk for developing multidrug resistant tuberculosis (MDR-TB) which is an infection that does not get better with standard treatment for TB. HHC means any person that lives with, has lived with, or shared housekeeping duties in a home or the same place with a person (an Index Case) who has pulmonary MDR-TB (a lung infection or pneumonia with TB) and started treatment for MDR-TB within the past 90 days. It is also for people who have spent more than 4 hours indoors with the index case, during the week before they started MDR-TB treatment.
High-risk household contacts are those with HIV or an immune system problem not from HIV like cancer , latent TB infection (a history of TB infection in the past based on testing), and young children below the age of 5 years.
Tuberculosis
Closed to accrual
A5343: A Trial of the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, among Participants Taking Multidrug Treatment for Drug-Resistant Pulmonary Tuberculosis
This is a randomized study, which means, by chance, you will be in one of three groups. You have an equal chance of being assigned to a group like flipping a coin. A5343 is an open label clinical trial, which means you will know which group you are in and what medications you will be taking.
This study will compare three treatment arms for people who have pulmonary multidrug resistant tuberculosis (MDR-TB). Pulmonary MDR-TB is a form of tuberculosis (TB) in the lung that is resistant to two or more of the primary drugs used for the treatment of TB (isoniazid and rifampin).
You will receive standard treatment for MDR-TB plus one or two new drugs for TB, called bedaquiline (BDQ) and delamanid (DLM). Throughout the study, you will be monitored to make sure that there are no safety concerns. Your heart will be monitored closely to make sure it is safe to give the drugs together.
Hepatitis
Closed to accrual
A5379: B-ENHANCEMENT OF HBV VACCINATION IN PERSONS LIVING WITH HIV (BEe-HIVe): Evaluation of HEPLISAV-B
A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the vaccine did not respond well and individuals who have never received the vaccination. The study will take place both in the US and internationally. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses.
COVID-19 and Mpox