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Could a Custom-Made vaccine help control HIV without daily pills?

NCT ID NCT00510497

Disease control Sponsor: Sharon Riddler Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small early-phase trial tested a personalized vaccine for HIV made from each patient's own immune cells and inactivated virus. Eleven HIV-positive volunteers who had never taken antiretroviral therapy received the vaccine and then temporarily stopped their regular HIV medications. The main goals were to check safety and see if the vaccine could lower the amount of virus in the blood, potentially allowing people to control HIV without daily pills.

What this could mean

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

Active substance
autologous dendritic cell vaccine (made from the patient's own immune cells and inactivated HIV)
What this could lead to
If it works, this could point toward a way to control HIV without needing daily antiretroviral drugs, potentially reducing long-term side effects and treatment burden.
What could go wrong
This is a very small, early-phase trial with only 11 participants, so results may not apply broadly. The vaccine may not lower viral load enough, and there is a risk of side effects from the treatment interruption.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

11 people

The number who actually took part.

Started

Jul 2007

Finished

Sep 2012

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: * Confirmed HIV-1 infection. * CD4 greater than or equal to 350 cells/mL within 8 weeks prior to study entry. * Plasma HIV-1 RNA level of 5000-100,000 copies/mL within 8 weeks prior to study entry. * Antiretroviral therapy naive. * Willingness to interrupt ART for at least 12 weeks. * Written informed consent. Exclusion Criteria: * Treatment within 30 days prior to study entry with systemic steroids or other immunosuppressives, or any underlying disease which may require use of such medications during the study period. * Receipt of any vaccinations other than routine ones within 6 months of study entry * Pregnancy or breastfeeding * Previous or current CDC Category C event * Receipt of any investigational product within 12 weeks prior to study entry.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

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

HIV infections

Contacts and locations

Locations

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.