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Could HIV patients safely pause their meds? new study explores

NCT ID NCT00820118

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether people with HIV who have high immune cell counts (CD4 above 500) can safely take antiretroviral drugs in 6-month cycles—6 months on treatment, then 6 months off—instead of taking them every day. The goal was to see if this approach could keep their immune system stable and offer a more flexible treatment option. The trial involved 45 adults who had never taken HIV medication before.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

45 people

The number who actually took part.

Start date

May 2009

Finished

May 2012

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: * adult confirmed HIV-1 infection * no previous treatment with antiretroviral drugs or interleukin-2 * CD4 count ≥ 500/mm3 * no active opportunistic infection * written informed consent Exclusion Criteria: * non barrier contraception in women of child bearing potential, pregnant or breastfeeding woman, pregnancy project within the next 2 years * HIV-2 infection (with or without HIV-1), recent HIV primary infection, resistance to trial drugs at study entry, Ag HBs+, HCV requiring specific therapy * previous history of cerebrovascular accident or coronary heart disease, splenectomy * previous CD4 count \< 400/mm3 * CD4 percentage \< 15% * hemoglobin \< 8 g/dl, neutrophils \< 750/mm3, platelets \< 100.000/mm3, creatinine clearance \< 50 ml/mn, AST or ALT or total bilirubin \> 3 ULN

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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

  • Services maladies infectieuses et tropicales CHU

    Dijon, France

More trials for these conditions

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