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NCT06829238 · ClinicalTrials.gov registry record · Phase 4
Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use
A Phase 4 study of HIV and Systemic Inflammation, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06829238: Recruiting Phase 4 study of HIV and Systemic Inflammation, sponsored by University of Alabama at Birmingham.
NCT06829238 is a Phase 4 study of HIV and Systemic Inflammation that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 100 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06829238, a Phase 4 study of HIV and Systemic Inflammation, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic inflammation and improve immune function in individuals with a history of injection drug use, with or without HIV. Participants will receive metformin or placebo and undergo immune system assessments, including vaccine response evaluations.
Primary Outcome
Assessed by Enzyme Linked Immunosorbent Assay (ELISA) of blood samples collected at baseline and at 16 weeks. Reported in mg/dL.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Metformin
- BIOLOGICAL Jynneos
- BIOLOGICAL Capvaxvie
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-04-07 |
| Est. Completion | 2029-11-30 |
| Phase | Phase 4 |
What NCT06829238 shows while recruiting
NCT06829238 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 440-participant average among 303 other HIV trials with a reported enrollment target (77% lower).
The record links to 4 conditions, with HIV appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06829238 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06829238 about?
NCT06829238 is a clinical study titled "Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use". This randomized clinical trial (RCT) evaluates whether metformin can reduce systemic inflammation and improve immune function in individuals with a history of injection drug use, with or without HIV. Participants will receive metformin or placebo and undergo immune system assessments, including vacc...
What is the current status of trial NCT06829238?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2025-04-07. Estimated completion is 2029-11-30.
What conditions does trial NCT06829238 study?
This clinical trial studies the following conditions: HIV, Systemic Inflammation, Injection Drug Use, Immune Dysregulation.
What interventions are being tested in trial NCT06829238?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Jynneos (BIOLOGICAL), Capvaxvie (BIOLOGICAL).
Who is sponsoring clinical trial NCT06829238?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06829238 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06829238's enrollment target sits among peer trials
100 150th of 303 higher than 142 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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