One pill a day for HIV and TB? new study tests simpler regimen
NCT ID NCT00115609
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a once-daily combination of three HIV drugs (tenofovir, emtricitabine, and efavirenz) in 70 adults with both HIV and tuberculosis. Participants had not taken HIV medication before and had been on TB treatment for less than three months. The goal was to see if this simpler, once-daily pill routine was safe and effective at controlling HIV while treating TB.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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70 people
The number who actually took part.
- Start date
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Jan 2006
- Finished
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Nov 2009
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients ≥ 18 years * Infected by HIV-1 * Naive to antiretroviral therapy * Presenting an indication to start antiretroviral therapy (according to the recommendations of the Delfraissy 2004 report) * Histologically or microbiologically confirmed tuberculosis * Receiving tuberculostatic therapy for less than three months Exclusion Criteria: * Isolated HIV-2 infection * Neoplasm treated by chemotherapy and/or radiotherapy * Pregnancy or plans for pregnancy * Breastfeeding * Contraindication to one of the antiretroviral drugs * Atypical mycobacterial infection * Hemoglobin below 8 g/dL * Neutrophils below 750/mm3 * Platelets below 50,000/mm3 * Creatinine clearance below 60 ml/min * Alkaline phosphatase, ASAT, ALAT or bilirubin over 3 times the upper limit of normal
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Service des maladies Infectieuses et tropicales Hopital Necker-Enfants Malades
Paris, 75015, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?