HIV patients may do just as well on fewer drugs, new study suggests
NCT ID NCT04054089
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at HIV-positive adults who switched from a standard three-drug therapy to either a two-drug or a three-drug regimen. Researchers wanted to see if the two-drug option could reduce long-term side effects while keeping the virus under control. The main focus was on changes in immune system markers like CD8 cells and the CD4/CD8 ratio. Results help doctors choose safer long-term treatments for people living with HIV.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
66 people
The number who actually took part.
- Started
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Jan 2020
- Finished
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Feb 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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
-
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: 1. Age = 18 years 2. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures 3. Patients infected by HIV-1 4. Patients under the first-line cART regimen with three antiretrovirals 5. HIV-RNA \<=50 copies/mL for at least 12 months 6. No previous virological failures/blips 7. A female subject is eligible to enter the study if it is confirmed that she is: * Not pregnant or nursing * Of non-childbearing potential (e.g., women who have had a hysterectomy, have had both ovaries removed or medically documented ovarian failure, or are postmenopausal women \>54 years of age with cessation for =12 months of previously occurring menses) * Of chilbearing potential and agrees to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following discontinuation of study drugs * Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing 8. Male subjects must agree to utilize a highly effective method of contraception (as defined in Appendix 5) during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose. 9. Male subjects must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose. Exclusion Criteria: 1. Patients with chronic hepatitis B 2. Pregnant or breastfeeding women 3. Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance 4. Known hypersensitivity to B/F/TAF FDC tablets, DTG and 3TC, their metabolites, or formulation excipient 5. Subjects receiving ongoing therapy with any of the following medications in the table below, including drugs not to be used with B, F, TAF, DTG and 3TC. Administration of any of the previous medications must be discontinued at least 30 days prior to the Day 1 visit and for the duration of the study 6. Documented resistance to any of the study drugs 7. Active, serious infection (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1. 8. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with protocol requirements. -
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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
-
University Hospital of Modena- Infetious Diseases Clinic
Modena, 41124, Italy
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Other studies related to the condition(s) this trial covers.
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