Summary
Nicotine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in HIV/AIDS would be drug repurposing rather than first-in-human development. This does not mean it is approved for HIV/AIDS. ClinicalTrials.gov lists 8 registered trials linking Nicotine to HIV/AIDS: 1 is currently recruiting; 1 is active or not yet recruiting; 6 have completed. The most advanced is Phase 4 (NCT05030766). The largest enrolment is 7720 participants (NCT03224741). Registration activity spans 2011 to 2025. The literature layer holds 7 publications for this pair: 1 Cochrane review, 1 meta-analysis and 5 clinical trial publications. Publication years run from 2022 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for HIV/AIDS ranks 249 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous elite control (natural viremic suppression without ART) in <1% of people living with HIV; untreated, median time to AIDS ~10 years; viral rebound within weeks of ART interruption in 99%+ of patients.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 62.0 (trials 23.0, literature 19.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 6 completed, 0 other |
| Linked publications | 7 (5 clinical trial publications, 1 Cochrane review, 1 meta-analysis) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | AP2A1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT05030766 | Testing Integrative Smoking Cessation for HIV Patients 2022 | completed | Phase 4 | 95 |
| NCT05852860 | A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research 2023 | active, not recruiting | Not applicable | 500 |
| NCT05162911 | Implementing Tobacco Use Treatment in HIV Clinics Vietnam 2021 | completed | Not applicable | 672 |
| NCT03904186 | Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in People Living With HIV 2019 | completed | Not applicable | 131 |
| NCT01393301 | Integrated Treatment for Smoking Cessation & Anxiety in People With HIV 2011 | completed | Not applicable | 72 |
| NCT03224741 | Behavioral Economics Field Experiment in HIV Testing 2017 | completed | Not applicable | 7,720 |
| NCT02781090 | RCT of an Internet Cessation Program Plus Online Social Network for HIV+ Smokers 2016 | completed | Not applicable | 512 |
| NCT06880705 | The Trans-Led Care Study 2025 | recruiting | Not applicable | 124 |
Published literature
- Clinical trial publication Clinical Pharmacists, Medications, and Contingency Management for Targeting Smoking in HIV Clinics: A Randomized Clinical TrialEdelman EJ, Deng Y, Dziura J et al. · JAMA network open · 2026 · PMID 41758512
- Clinical trial publication Effectiveness of behavioural tobacco cessation interventions with and without pharmacotherapy among people living with HIV in Viet Nam: a three-arm pragmatic randomised controlled trialShelley D, Armstrong-Hough M, Nguyen T et al. · The Lancet. Global health · 2026 · PMID 41713442
- Clinical trial publication Assessing the impact of nicotinic partial agonists compared to NRT on opioid and cigarette use: A secondary analysis investigating treatment outcomes for co-occurring nicotine and opioid useRich ZC, Tindle HA, Cheng DM et al. · Journal of substance use and addiction treatment · 2026 · PMID 41558587
- Clinical trial publication Population reach, feasibility and acceptability of digital therapeutics for smoking cessation among people living with HIV: Results of the Quitting Matters pilot trialVilardaga R, McClernon FJ, Akingbule O et al. · Drug and alcohol dependence · 2026 · PMID 41512654
- Clinical trial publication Galantamine for 12 weeks does not improve neurocognition or immune activation in ART-suppressed people with HIVYadav A, Stephens-Shields AJ, Karaj A et al. · AIDS (London, England) · 2026 · PMID 41427614
- Cochrane review Interventions for tobacco use cessation in people living with HIVMdege ND, Shah S, Dogar O et al. · The Cochrane database of systematic reviews · 2024 · PMID 39101506
- Meta-analysis Meta-Analysis on Nicotine's Modulation of HIV-Associated DementiaKrishnan V, Vigorito M, Kota NK et al. · Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2022 · PMID 34757527
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AP2A1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Nicotine approved for HIV/AIDS?
Nicotine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in HIV/AIDS would be drug repurposing rather than first-in-human development. This does not mean it is approved for HIV/AIDS. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Nicotine in clinical trials for HIV/AIDS?
ClinicalTrials.gov lists 8 registered trials linking Nicotine to HIV/AIDS: 1 is currently recruiting; 1 is active or not yet recruiting; 6 have completed. The most advanced is Phase 4 (NCT05030766). The largest enrolment is 7720 participants (NCT03224741). Registration activity spans 2011 to 2025.
What does the evidence show for Nicotine in HIV/AIDS?
Nicotine has both completed registered trials and synthesis-level publications linked to HIV/AIDS. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AP2A1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.