What side effects are associated with this type of intervention?

Common treatments for HIV infection, such as antiretroviral therapy (ART), can have several side effects. These include gastrointestinal issues like nausea and diarrhea, metabolic changes such as lipodystrophy and insulin resistance, cardiovascular risks, liver toxicity, and renal impairment. Specific drugs within ART may have unique side effects; for instance, nucleoside reverse transcriptase inhibitors (NRTIs) can cause mitochondrial toxicity, and protease inhibitors (PIs) are linked to increased cholesterol levels.

What prior FDA approvals exist?

The FDA has approved several antiretroviral therapies for the treatment of HIV, focusing on combination regimens that include drugs from different classes to enhance efficacy and reduce resistance. Key drugs include nucleoside reverse transcriptase inhibitors (NRTIs) like tenofovir and emtricitabine, protease inhibitors (PIs) such as indinavir, and integrase strand transfer inhibitors (INSTIs) like bictegravir. These treatments are often used in combination to achieve better viral suppression, similar to the regimens being evaluated in trials for Point-of-Care Nucleic Acid Testing, which aim to rapidly detect and manage HIV infection.

What other types of research exist?

Promising novel alternatives to Point-of-Care Nucleic Acid Testing for HIV include CRISPR-based assays and ultrasensitive antigen tests. CRISPR-based assays offer high specificity and rapid results, while ultrasensitive antigen tests can detect low levels of HIV antigens, providing early diagnosis and monitoring capabilities. Both methods have the potential to enhance diagnostic accuracy and patient management in various settings.

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Nucleic Acid Test

POC NAT for HIV Detection and Care Management (GAIN Trial)

N/A

Recruiting

Led By Joanne D Stekler, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be enrolled for up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a quick on-site method to detect HIV's genetic material. It targets people who are either HIV-negative and seeking prevention or HIV-positive needing treatment. The goal is to provide immediate results to help start prevention or treatment quickly.

Who is the study for?

This trial is for adults over 18 who are HIV-positive and seeking care at Madison Clinic. They must be able to read and speak English, have their provider's approval to receive an adherence intervention, and be getting a lab RNA viral load test the same day.

What is being tested?

The study tests point-of-care nucleic acid testing (POC NAT) in community and clinical settings for its accuracy in detecting HIV, impact on PrEP use among HIV-negative individuals, care outcomes for those positive, and time to virus suppression with tailored behavioral interventions.

What are the potential side effects?

Since this trial focuses on diagnostic testing methods rather than medications or treatments, direct side effects from the interventions are not applicable. However, there may be indirect impacts related to receiving test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be enrolled for up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be enrolled for up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be enrolled for up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to viral suppression

Secondary study objectives

Participation

Other study objectives

POC NAT limit of detection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: POC NAT & Adherence InterventionExperimental Treatment1 Intervention

These participants will receive the POC NAT test during their study visit. The result will be conveyed to their provider, who will deliver the result and an adherence intervention.

Group II: Standard of CareActive Control1 Intervention

These participants will receive the clinical standard of care during their visit.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HIV infection include integrase strand transfer inhibitors (InSTIs) and nucleoside reverse transcriptase inhibitors (NRTIs). InSTIs work by blocking the integrase enzyme, which is essential for the integration of viral DNA into the host cell genome, thereby preventing viral replication. NRTIs inhibit the reverse transcriptase enzyme, which is necessary for converting viral RNA into DNA, a critical step in the viral life cycle. These treatments are vital for HIV patients as they significantly reduce viral load, improve immune function, and decrease the risk of HIV-related complications. Rapid detection of HIV RNA through point-of-care nucleic acid testing can facilitate timely initiation and adjustment of these therapies, enhancing treatment outcomes.

Advances in antiretroviral therapy.[Viral infections in pediatric cancer patients].Quantitation of human immunodeficiency virus type 1 group O load in plasma by measuring reverse transcriptase activity.