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Could a Two-Drug HIV combo protect babies without extra side effects?

NCT ID NCT00424814

Prevention 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a simpler HIV drug combination (lopinavir/ritonavir alone) could safely prevent mothers from passing HIV to their babies during pregnancy, compared to the standard three-drug combo. About 105 pregnant women with well-controlled HIV took part. The goal was to see if the simpler regimen could keep virus levels low enough to protect the baby while reducing drug side effects.

What this could mean

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

Active substance
Lopinavir/ritonavir (Kaletra) with or without zidovudine/lamivudine (Combivir)
What this could lead to
If successful, this could offer a safer, simpler way to prevent HIV transmission from mother to child during pregnancy, reducing drug side effects for both.
What could go wrong
This is a small, early-phase study (105 participants) that may not prove generalizable. The simpler regimen might not suppress the virus as well as standard combinations.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

105 people

The number who actually took part.

Start date

Mar 2007

Finished

Nov 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

Female participants only

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: Assessed between 20 and 24 months of pregnancy * Pregnancy known before 24 weeks of gestation * Documented HIV-1 infection without indication for ARV therapy * CD4 count above or equal to 350 per mm3 * VL under 30 000 copies per ml * Naïve for PI (except treatment during previous pregnancy) * Informed consent signed Exclusion Criteria: * HIV2 infection or HIV1 group O infection * Any pathology related to pregnancy * Contra-indication to study drugs * Unstable hypertension or diabetes * Known risk of premature delivery * In case of previous treatment with a protease inhibitor : presence of resistance mutations on the HIV-1 protease gene by genotyping analysis (1 mutation among V32I et I47A, I50V V82A/F/S/T, I84V, L90 M or more than 3 mutations among L10 F/I/R/V, K20/M/R, L24I, L33F, M46I/L, F53L, I54M/L/T/V, L63P, A71L/V/T,)

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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

  • Hopital Pitie salpetriere

    Paris, 75013, France

More trials for these conditions

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