What side effects are associated with this type of intervention?

Common treatments for HIV/AIDS, primarily antiretroviral therapy (ART), can have a range of side effects. These may include gastrointestinal issues (nausea, diarrhea), fatigue, headache, and dizziness. Some patients may experience more severe effects such as liver toxicity, kidney problems, or metabolic changes like lipodystrophy. Varenicline, a partial agonist at nicotinic acetylcholine receptors, is being studied for tobacco cessation in HIV care and is generally associated with side effects such as nausea, vomiting, and insomnia. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved numerous antiretroviral drugs for the treatment of HIV/AIDS, which primarily include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. These drugs work by targeting different stages of the HIV life cycle to prevent the virus from replicating. While Varenicline is being studied for smoking cessation in HIV care, it is not directly related to the antiretroviral treatments for HIV/AIDS. Therefore, no prior FDA approvals for HIV/AIDS treatment are similar to Varenicline's mechanism of action as a partial agonist at nicotinic acetylcholine receptors.

What other types of research exist?

Promising novel alternatives to Varenicline for HIV/AIDS patients in 2024 include Doravirine (a novel NNRTI) and the Positively Smoke Free - Mobile (PSF-M) program. Additionally, integrase transfer inhibitors such as raltegravir, elvitegravir, and dolutegravir may offer effective treatment options.

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Nicotinic Acetylcholine Receptor Partial Agonist

Varenicline + PSF-M for Smoking Cessation in HIV/AIDS

Q: What is the mechanism of action of this treatment?

The most common treatments for HIV/AIDS involve antiretroviral therapy (ART), which includes a combination of drugs from different classes such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. These drugs target various stages of the HIV life cycle to prevent the virus from replicating, thereby reducing the viral load and maintaining immune function. This comprehensive approach is essential for preventing the progression to AIDS and improving the quality of life for HIV patients. Addressing co-occurring conditions like tobacco dependence, as seen in the V+PSF-M trial with Varenicline, is also important for optimizing overall health outcomes.

Phase 3

Recruiting

Led By Gina Kruse, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Adults (≥18 years)

Be older than 18 years old

Must not have

Myocardial infarction in past 30 days or unstable angina

ALT and AST > 2 times ULN or creatinine clearance <50 in past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks post-randomization

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a mobile app and a medication to help people with HIV quit smoking. The app provides tips and support, while the medication reduces cravings. The study aims to see if this combination is more effective than standard care.

Who is the study for?

This trial is for adults over 18 with HIV who smoke tobacco, have a viral load under 1000 copies/mL, and CD4 count above 200 cells/mm3. They must read at a 6th-grade level in Tamil, Telugu or English and can safely use varenicline. Women must agree to contraception during the study.

What is being tested?

The study tests an intervention to help people with HIV quit smoking using PSF-M (a mobile behavioral program) and Varenicline (a medication). Participants will receive either this combination or standard care to see which helps more with quitting.

What are the potential side effects?

Varenicline may cause nausea, sleep problems, constipation, gas, vomiting. It can also lead to mood changes or trouble driving/operating machinery due to drowsiness.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a heart attack or unstable chest pain in the last 30 days.

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My liver enzymes are high or my kidney function is low.

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I have a history of psychosis or am taking anti-psychotic medications.

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I have major depression that is either untreated or not well-controlled.

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I am able to understand and consent to the trial on my own.

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I am currently having thoughts about harming myself.

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I have had liver or kidney failure in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks post-randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

7-Day Point Prevalent Abstinence Rate

Secondary study objectives

7-day self-reported Point Prevalent Abstinence Rate

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Varenicline + Positively Smoke Free - MobileExperimental Treatment2 Interventions

Offer of varenicline per package dosing with dose escalation over week 1: 0.5 mg once daily on days 1 - 3, 0.5 mg twice daily on days 4 -7, followed by 1.0 mg twice daily on days 8 to 84. Offer of Positively Smoke Free Mobile delivered by mobile phone including 42 days of content, tailored to individual quit date.

Group II: Standard CareActive Control1 Intervention

Brief advice to quit tobacco Offer of referral to the national tobacco quitline

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Varenicline

2011

Completed Phase 4

~4170

0 / 8Eligibility 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

The most common treatments for HIV/AIDS involve antiretroviral therapy (ART), which includes a combination of drugs from different classes such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. These drugs target various stages of the HIV life cycle to prevent the virus from replicating, thereby reducing the viral load and maintaining immune function. This comprehensive approach is essential for preventing the progression to AIDS and improving the quality of life for HIV patients. Addressing co-occurring conditions like tobacco dependence, as seen in the V+PSF-M trial with Varenicline, is also important for optimizing overall health outcomes.

Lessons learned from HIV treatment interruption: safety, correlates of immune control, and drug sparing.