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Could a single daily pill replace complex HIV regimens?

NCT ID NCT00196612

Disease control Sponsor: ANRS, Emerging Infectious Diseases 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial compares a once-daily combination of three HIV drugs (emtricitabine, didanosine, and efavirenz) to the standard multi-pill regimen containing a protease inhibitor. The goal is to see if the simpler daily pill works just as well at keeping the virus undetectable, while causing fewer side effects and being easier for patients to take. The study includes adults with HIV who have had an undetectable viral load for at least six months on their current therapy.

What this could mean

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

Active substance
emtricitabine, didanosine, efavirenz
What this could lead to
If successful, this could offer people with HIV a simpler, once-daily treatment option with fewer side effects and better quality of life.
What could go wrong
This is a phase 3 trial, so results are not yet confirmed. The once-daily combo may prove less effective or cause unexpected side effects in some people.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

350 people

Start date

Apr 2001

Completion date

Sep 2004

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * HIV infected adults * Antiretroviral treatment since 6 months, with two nucleoside analogues and one or two protease inhibitors * CD4 cell count over 100/mm3 * HIV RNA below 400 copies/ml since 6 months * Signed written informed consent Exclusion Criteria: * Previous treatment with non nucleoside analogue, ddI alone * Pregnancy * Alcool abuse * Acute infection, past neurological or pancreatic disease, biological abnormalities * Chemotherapy or immunotherapy

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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

  • Service de Maladies Infectieuses, Hôpital Saint-Louis

    Paris, 75475, France

More trials for these conditions

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