Amphotec

Cerebral Cryptococcosis, Histoplasmosis, Coccidioidomycosis + 25 more

Treatment

28 FDA approvals

20 Active Studies for Amphotec

What is Amphotec

Amphotericin B

The Generic name of this drug

Treatment Summary

Amphotericin B is an antibiotic used to treat fungal infections caused by a variety of species including Histoplasma capsulatum, Coccidioides immitis, Candida species, Blastomyces dermatitidis, and more. It is often effective against Candida albicans, although other species may be less susceptible. Pseudallescheria boydii and Fusarium sp. are usually resistant to the drug. It is not effective against bacteria, rickettsiae, or viruses.

Fungizone

is the brand name

Amphotec Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Fungizone

Amphotericin B

1966

10

Approved as Treatment by the FDA

Amphotericin B, otherwise called Fungizone, is approved by the FDA for 28 uses like severe Fungal infection caused by Basidiobolus spp. and severe Fungal infection caused by Conidiobolus spp. .

severe Fungal infection caused by Basidiobolus spp.

severe Fungal infection caused by Conidiobolus spp.

severe Mucocutaneous leishmaniasis

severe Fungal infection caused by sporotrichosis spp.

severe North American blastomycosis

Histoplasmosis

Leishmaniasis, Visceral

Sporotrichosis

Mycoses

Cryptococcosis

Febrile Neutropenia

failed previous amphotericin B treatment

Used to treat failed previous amphotericin B treatment in combination with DL-dimyristoylphosphatidylcholine

severe Histoplasmosis

Visceral Leishmaniasis

severe Cryptococcosis

severe Systemic candidiasis

Mucocutaneous Leishmaniasis

Meningitis, Cryptococcal

Febrile Neutropenia

Leishmaniasis, Cutaneous

Gilchrist Disease

Coccidioidomycosis

Systemic candidiasis

Leishmaniasis, Mucocutaneous

Mycoses

Cerebral Cryptococcosis

HIV

Invasive Fungal Infections

Effectiveness

How Amphotec Affects Patients

Amphotericin B is an effective antifungal drug that can be used to treat a wide range of fungi, including Histoplasma capsulatum, Coccidioides immitis, Candida species, and Blastomyces dermatitidis, among others. It does not work on bacteria, rickettsiae, or viruses. The effectiveness of Amphotericin B on Candida albicans is usually good, but it is usually not as effective on other non-albicans species. Pseudallescheria boydii and Fusarium species are usually resistant to this drug.

How Amphotec works in the body

Amphotericin B is a drug that can kill or stop the growth of certain types of fungi. It works by binding to a part of the cell membrane, called ergosterol, in susceptible fungi. This binding creates a channel in the membrane, which changes how it interacts with other molecules. This change leads to the leakage of important components from inside the cell, eventually leading to the death of the cell.

When to interrupt dosage

The proposed dosage of Amphotec is contingent upon the diagnosed condition, for example Aspergillosis, serious Cryptococcosis and serious Mucocutaneous leishmaniasis. The dosage also varies as per the mode of administration referenced in the table beneath.

Condition

Dosage

Administration

Cerebral Cryptococcosis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

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Tuberculosis, Osteoarticular

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

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Aspergillosis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

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Gilchrist Disease

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

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Coccidioidomycosis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

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Systemic candidiasis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

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Mycoses

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

Aspergillosis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

Cystitis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

Histoplasmosis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

Leishmaniasis, Cutaneous

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

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Mycoses

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

Sporotrichosis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

failed previous amphotericin B treatment

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

Leishmaniasis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

Cryptococcosis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

Histoplasmosis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

Coccidioidomycosis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

Cryptococcosis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

Endophthalmitis

, 5.0 mg/mL, 5.0 mg/mg, 1.0 mg/mg, 50.0 mg, 100.0 mg, 30.0 mg/mL, 10.0 mg/mL

Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, , Injection, lipid complex - Intravenous, Injection, lipid complex, Powder, for suspension - Intravenous, Powder, for suspension, Suspension - Intravenous, Suspension, Cream - Topical, Lotion - Topical, Injection, Injection - Intravenous, Powder, for solution, Powder, for solution - Intravenous, Topical

Warnings

There are 20 known major drug interactions with Amphotec.

Common Amphotec Drug Interactions

Drug Name

Risk Level

Description

Cyclosporine

Major

Amphotericin B may increase the nephrotoxic activities of Cyclosporine.

Neomycin

Major

The risk or severity of nephrotoxicity can be increased when Amphotericin B is combined with Neomycin.

Tenofovir

Major

Amphotericin B may increase the nephrotoxic activities of Tenofovir.

Tenofovir alafenamide

Major

Amphotericin B may increase the nephrotoxic activities of Tenofovir alafenamide.

Tenofovir disoproxil

Major

Amphotericin B may increase the nephrotoxic activities of Tenofovir disoproxil.

Amphotec Toxicity & Overdose Risk

The toxic dose for rats is more than 5 grams per kilogram. If someone overdoes on amphotericin B, it could lead to cardiopulmonary arrest.

Amphotec Novel Uses: Which Conditions Have a Clinical Trial Featuring Amphotec?

At present, 10 active trials are assessing the utility of Amphotec in addressing Meningeal Fungal Infections, such as Histoplasmosis.

Condition

Clinical Trials

Trial Phases

Tuberculosis, Osteoarticular

0 Actively Recruiting

Coccidioidomycosis

0 Actively Recruiting

Cerebral Cryptococcosis

1 Actively Recruiting

Phase 2, Phase 3

Mycoses

0 Actively Recruiting

Aspergillosis

0 Actively Recruiting

Cryptococcosis

0 Actively Recruiting

Histoplasmosis

0 Actively Recruiting

Meningitis, Fungal

0 Actively Recruiting

Histoplasmosis

1 Actively Recruiting

Phase 3

Systemic candidiasis

3 Actively Recruiting

Phase 3, Phase 2

Febrile Neutropenia

3 Actively Recruiting

Phase 2, Not Applicable

Cryptococcosis

0 Actively Recruiting

talaromycosis

0 Actively Recruiting

Leishmaniasis, Cutaneous

0 Actively Recruiting

Invasive Fungal Infections

3 Actively Recruiting

Phase 3, Phase 2

Endophthalmitis

0 Actively Recruiting

Mycoses

0 Actively Recruiting

Leishmaniasis, Mucocutaneous

0 Actively Recruiting

Aspergillosis

0 Actively Recruiting

Gilchrist Disease

0 Actively Recruiting

Amphotec Reviews: What are patients saying about Amphotec?

4.3

Patient Review

11/30/2009

Amphotec for An Infection caused by the Fungus Zygomycetes

My husband takes this medication intravenously, and we have found that it works best if he takes two Tylenol, 25mg of Benadryl, and 50mg of hydrocortisone about 30 to 45 minutes before the infusion. If he starts shaking, we give him 12.5mg of Demerol. We've been doing this for three weeks now with good results.

4

Patient Review

6/22/2008

Amphotec for Infection with Cryptococcus Fungus

I developed tinnitus during my treatment, which was a real bummer.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about amphotec

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Clinical Trials for Amphotec

Image of New Jersey Community Research Initiative in Newark, United States.

AI-DBT for Suicide Prevention in HIV/AIDS

18+
All Sexes
Newark, NJ

One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population. Currently, there are no behavioral interventions that specifically address suicide prevention for older PLWHA, despite their unique biopsychosocial and structural risk factors. Through this work, investigators will adapt Dialectical Behavior Therapy, an evidence-based intervention for suicide prevention, for patients with PLWHA to be delivered by an AI-powered conversational Agent developed by our industry partner, Empower Health. Investigators will then pilot test the feasibility, usability, acceptability and preliminary efficacy to improve self-efficacy to manage negative emotions in n=50 older adults living with HIV/AIDS.

Recruiting
Has No Placebo

New Jersey Community Research Initiative (+1 Sites)

Elissa Kozlov, PhD

Image of George Washington University Emergency Department in Washington D.C., United States.

Decision Support Tool for HIV Prevention

18+
All Sexes
Washington D.C., United States

This project will explore the development of a personalized decision support tool to assist with pre-exposure prophylaxis (PrEP) initiation and persistence among patients identified in the emergency department (ED) and urgent care settings as PrEP eligible. First, the investigators will use a sequence of validated implementation science methodologies to develop and validate a decision support tool designed to optimize PrEP persistence by strengthening self-efficacy by addressing the multifaceted medical and social needs of the individual patient. The investigators will then test the preliminary effectiveness of this tool through a pilot stepped wedge implementation trial in two EDs and an urgent care in Baltimore, MD and Washington, DC among 120 PrEP eligible patients to determine PrEP initiation, linkage to care, persistence, and adherence rates.

Phase 1
Waitlist Available

George Washington University Emergency Department (+1 Sites)

Image of The University of Alabama at Birmingham in Birmingham, United States.

Behavioral vs Mindfulness Treatments for Insomnia in HIV

50 - 99
All Sexes
Birmingham, AL

The goal of this clinical trial is to examine the effects of a telephone-delivered Brief Behavioral Treatment Insomnia (BBTI) versus a Brief Mindfulness Treatment (BMT) on cognitive and sleep outcomes in older adults with HIV. The main questions it aims to answer are: What are the effects of BBTI vs BMT on self-reported and observed sleep outcomes in older adults with HIV and insomnia up to 1-year post-intervention? What are the effects of BBTI vs BMT on self-reported and observed cognitive comes in older adults with HIV and insomnia up to 1-year post-intervention? What is the association between Alzheimer's Disease biomarkers and sleep and cognitive outcomes in older adults with HIV receiving BBTI vs BMT? Participants will: * Complete 4 weeks of telephone-delivered BBTI or BMT * Attend baseline, post-intervention, and 1-year post in-person visits for sleep and cognitive assessments * Have blood collected at all three time points

Waitlist Available
Has No Placebo

The University of Alabama at Birmingham (+1 Sites)

Dr. Shameka L Cody, PhD, AGNP-C, PMHNP-BC, FAAN

Image of University of Minnesota in Minneapolis, United States.

LAmB and Posaconazole for Histoplasmosis

18+
All Sexes
Minneapolis, MN

The purpose of the study is threefold: 1. Assess the safety and efficacy of a single high-dose intravenous (LAmB 10mg/kg) compared to the SOC daily dosing (3mg/kg) of the same medication for induction therapy in moderate to severe histoplasmosis. 2. Assess the safety and efficacy of oral posaconazole 300mg delayed-release tablets three times daily for two days then once daily for consolidation therapy compared to SOC oral itraconazole 200 mg capsules three times daily for three days then twice daily in moderate to severe histoplasmosis 3. Assess the safety and efficacy of 6 months of consolidation therapy compared to the SOC 12 months of consolidation therapy in persons with HIV on appropriate antiretroviral therapy.

Phase 3
Waitlist Available

University of Minnesota

Nathan Bahr, MD

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We made a collection of clinical trials featuring Amphotec, we think they might fit your search criteria.
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Image of Los Angeles General Medical Center in Los Angeles, United States.

Decision Support Tool for HIV Treatment

18+
All Sexes
Los Angeles, CA

This study is testing software designed to help healthcare providers choose the best HIV treatment combinations for their patients. HIV medicines, known as antiretroviral therapy (ART), can be complex to manage because the right regimen depends on many factors-such as drug resistance, other health conditions, and medication schedules. Many people with HIV are cared for by general clinicians who may not have access to HIV specialists, which can make treatment decisions more challenging. In this study, healthcare providers will use patient cases to compare standard HIV treatment resources with a new clinical decision support tool that gives evidence-based ART recommendations at the point of care. The investigators hypothesize that using the tool will help providers select treatment plans that better match clinical guidelines, make decisions faster, reduce mental effort, and increase overall satisfaction with the prescribing process.

Waitlist Available
Has No Placebo

Los Angeles General Medical Center

Hayoun Lee, PhD

Image of University of North Carolina in Chapel Hill, United States.

MGD020 + MGD014 for HIV

18 - 65
All Sexes
Chapel Hill, NC

This research study aims to find out how safe and well tolerated the experimental study drugs are when given to persons with HIV (PWH) taking antiretroviral therapy (ART). The study treatments are MGD014 and MGD020, which are two antibodies developed specifically for HIV, and Vorinostat, an oral medication to help expose HIV in cells to the antibodies. The study will measure the impact of study treatment on non-active HIV in cells, and how long MGD014 and MGD020 stay in the body after they are given. In this study, participants will be randomly assigned to one of three groups. All participants receive MGD014 and MGD020, given sequentially as infusions through an IV for 4 doses. Participants in one group (group A) receive only MGD014 and MGD020. Participants in another group (group B) will stop taking their ART therapy for up to 8 weeks (a temporary treatment interruption (TTI)) while receiving MGD014 and MGD020. Participants in the third group (group C) receive Vorinostat in addition to MGD014 and MGD020. Total time of participation is about 8 months and involves 13 or 18 visits, depending on group assignment.

Phase 1
Recruiting

University of North Carolina

Cynthia L. Gay, MD

Image of Center on Substance Use and Health in San Francisco, United States.

CHAMPION Intervention for Pre-exposure Prophylaxis Adherence

18 - 40
Male
San Francisco, CA

The goal of this randomized controlled trial is to pilot test new mobile health (mHealth) interventions to improve PrEP adherence among HIV-negative men who have sex with men (MSM) with mild to moderate methamphetamine use disorder (MUD). The CHAMPION intervention combines two mHealth tools-PrEPAPP and CBT4CBT-to address both HIV prevention and MUD treatment needs in this population. The study's specific aims are: * To evaluate the feasibility and acceptability of the CHAMPION intervention based on treatment retention and engagement rates. * To examine the preliminary efficacy the CHAMPION intervention to improve PrEP adherence, as measured by dried blood spot (DBS) tests compared to the waitlist control group.

Waitlist Available
Has No Placebo

Center on Substance Use and Health

Glenn-Milo Santos, PhD, MPH

Have you considered Amphotec clinical trials?

We made a collection of clinical trials featuring Amphotec, we think they might fit your search criteria.
Go to Trials

Have you considered Amphotec clinical trials?

We made a collection of clinical trials featuring Amphotec, we think they might fit your search criteria.
Go to Trials