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HIV patients may ditch combo therapy for One-Pill option, study finds

NCT ID NCT00421551

Disease control Sponsor: French National Agency for Research on AIDS and Viral Hepatitis Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether HIV patients with long-term viral suppression could switch to a single boosted drug (darunavir/r) instead of staying on a standard combination of drugs. 225 adults with well-controlled HIV took part. The goal was to see if the single-drug approach could keep the virus undetectable for 48 weeks. The results help doctors understand if simpler treatment is safe and effective for some patients.

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

225 people

The number who actually took part.

Start date

Mar 2007

Finished

Feb 2011

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: * Confirmed HIV-1 infection. * Documented level of HIV-1 RNA at initiation of antiretroviral treatments * Prior antiretroviral regimen, including at least 2 NRTIs combined to 1 PI or NNRTI or a third NRTI for at least 18 months prior to study entry. * CD4 count of 200 cells per mm3 or greater. * Viral load below 400 copies per ml within 18 months prior to entry and below 50 copies per mL at entry. * Willing to use acceptable methods of contraception Exclusion Criteria: * Previous virological failure under prior PI-based regimen. * Prior therapy in the darunavir. * HIV-2 infected patients. * Absence of documented level of HIV-1 RNA at initiation of antiretroviral treatments * Hepatitis B or C infection within 90 days prior to study entry. * Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry. * Serious acute illness requiring systemic treatment or hospitalization in the 14 days prior to study entry. * Treatment for an active AIDS defining opportunistic infection within 30 days prior to screening * Drug or alcohol use or any dependence that would interfere with compliance. * Pregnancy or breastfeeding

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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 des maladies infectieuses et tropicales Hopital Pitie salpetriere

    Paris, 75013, France

More trials for these conditions

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