Early HIV treatment may shield immune cells from lasting damage

NCT ID NCT02656511

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether starting antiretroviral therapy right away during the first weeks of HIV infection can protect key immune cells from being destroyed. Adults with very early HIV (infected within the last 90 days) receive a combination of dolutegravir and emtricitabine/tenofovir. Researchers will measure safety, side effects, and changes in the amount of hidden HIV in the blood and tissues over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination of dolutegravir and emtricitabine/tenofovir
What this could lead to
If successful, this approach could help preserve immune function and reduce the amount of hidden HIV in the body, potentially leading to better long-term outcomes for people diagnosed early.
What could go wrong
This is a small, early-phase study without a comparison group, so results may not apply to everyone. The treatment may cause side effects, and it is not known if early treatment alone can eliminate the virus.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2015

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Male or female, age ≥18 years 3. Acute HIV infection with a negative or indeterminate HIV-1 antibody test and plasma HIV-1 RNA \> 40 cp/ml, OR clinical history consistent with new HIV infection in the last 90 days. 4. Antiretroviral therapy untreated or recently initiated (within 7 days) 5. Participant must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments. 6. All participants must agree not to participate in a conception process (eg, active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization).. 7. When participating in sexual activity that could lead to pregnancy, female participants must agree to use a double barrier method of contraception for at least two weeks after discontinuation of study drug. Exclusion Criteria: 1. Known severe kidney disease (CrCl \< 60 ml/min via Cockcroft-Gault method) 2. Known severe hepatic impairment (Child-Pugh Class C) 3. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) 4. Participants with anticipated need for Hepatitis C virus (HCV) therapy during study 5. Concurrent treatment with dofetilide, oxcarbazepine, phenytoin, phenobarbital, carbamazepine, St. John's wort, or metformin 6. Serious illness requiring systemic treatment and/or hospitalization in the preceding 90 days prior to study enrollment 7. Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drugs in the preceding 90 days prior to study enrollment (e.g. IL-2, interferon-alpha, methotrexate, cancer chemotherapy) 8. Concurrent treatment with investigational drugs, or exposure to any investigational drugs in the preceding 90 days prior to study enrollment 9. Active drug or alcohol use or dependence that, in the opinion of the Principal Investigator, would interfere with adherence to study requirements 10. Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation 11. Pregnant or breastfeeding women. 12. For participants who agree to colorectal biopsy 13. Known blood coagulation disorder 14. Platelets \< 50,000/mm\^3 15. PTT \> 2x upper limit of normal 16. INR \> 1.3 17. Use of aspirin, NSAIDs, Plavix, Coumadin, or other blood thinners that cannot be stopped for clinical reasons for 5 days before and after each colorectal biopsy 18. Inflammatory colitis (e.g., Crohn's disease and/or ulcerative colitis) and/or any contraindications to sigmoidoscopy or colorectal biopsy such as peritonitis, active diverticulitis, or recent bowel surgery

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • San Francisco General Hospital

    San Francisco, California, 94110, United States

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