HIV study tests which pill combo best shrinks the Virus's hideout
NCT ID NCT02987530
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two different once-daily HIV medication combinations in 101 people who had just been infected with HIV-1. The goal was to see which combo better lowered the amount of hidden virus in immune cells after 48 weeks. Both treatments are standard HIV therapies, so this research aims to improve long-term disease control rather than cure the infection.
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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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101 people
The number who actually took part.
- Started
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Apr 2017
- Finished
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Jan 2020
- 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
-
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.
Show the full entry requirements Hide 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: * Age ≥ 18 years at screening visit. * Patients with primary HIV-1 infection: Any results achieved in the previous 10 days of inclusion visit will be taken into account. If the Enzyme Linked ImmunoSorbent Assay (ELISA) test result does not dissociate the signals antibodies and p24 antigen or in case of rapid test result : * Negative ELISA / rapid test and positive HIV-1 RNA confirmed by a second positive HIV-1 RNA. * Positive ELISA / rapid test and WB-HIV1 \[0-5\] band (s) or IB-HIV-1 \[0-3\] band(s) confirmed by a positive HIV-1 RNA. If the ELISA test result dissociated p24 antigen and antibodies signals: * ELISA Ac - / p24 - and positive HIV-1 RNA confirmed by a second positive HIV-1 RNA. * ELISA Ac - / p24 + confirmed by a positive HIV-1 RNA. * ELISA Ac + / p24 + or - and WB-HIV1 \[0-5\] band (s) or IB-HIV-1 \[0-3\] band(s) confirmed by a positive HIV-1 RNA. * Written informed consent signed by the person and the investigator no later than the day of the screening visit and before any exam performed in the trial (article L1122-1-1 Public Health Code). * Affiliate or beneficiary of a social security system (Article L1121-11 of the Public Health Code) (the State Medical Aid or AME is not a social security system). * Patients followed in selected centers, accepting additional constraints and having signed a consent, will participate to virological, immunological and pharmacological sub-studies. * Patient agreeing to participate in the trial for 1 year according to the defined terms. Exclusion Criteria: * Any antiretroviral treatment (for Pre-Exposure Prohylaxis or Post-exposure prophylaxis) during the 4 weeks preceding inclusion. * Associated pathology with urgent care needed. * Prothrombin Ratio \< 50%. * Creatinine clearance \< 70 mL / min (Cockroft). * aspartate transaminase (AST), alanine transaminase (ALT), or bilirubin (total and conjugated) ≥ 10 times the upper limit of normal. * Patient with isolated HIV-2 viral strain. * Women of childbearing potential without effective contraception method (see appendix A6). * Pregnant or breastfeeding women. * Person under legal guardianship or deprived of liberty by a judicial or administrative decision. * Patient participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit. * Planned absence which could prevent optimal trial participation (vacation abroad, moving, imminent job change ...). * Co-administration of prohibited treatments (see § 9.5). * History or presence of allergy to the study drugs or their components; * Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification. * Any symptoms or laboratory values suggesting a systemic disorder (renal, hepatic, cardiovascular, pulmonary) or other medical conditions that could interfere with the interpretation of trial results or compromise the health of patients.
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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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Hopital Bicetre
All the Regions of the Country (40 Centers), France
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Other studies related to the condition(s) this trial covers.
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