HIV drug combo tested in 15 healthy volunteers
NCT ID NCT07002242
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 1 trial tested how the HIV drug azvudine (FNC) interacts with another HIV drug, Aluvia (lopinavir/ritonavir), in 15 healthy adults. Participants took the drugs alone and together over three 5-day cycles. The goal was to measure drug levels in the blood and check for side effects, to see if the combination could be used safely in future HIV treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Azvudine (FNC) and Aluvia (lopinavir/ritonavir)
- What this could lead to
- If successful, this could help doctors understand how to combine these two HIV drugs safely and effectively.
- What could go wrong
- This is a very early, small study in healthy people, not patients. It only looks at drug levels and safety, not whether the combination works against HIV or COVID-19.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
15 people
The number who actually took part.
- Started
-
Jul 2022
- Finished
-
Feb 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
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: 1. Healthy subjects aged ≥ 18 years old and ≤ 45 years old, regardless of gender; 2. Body mass index (BMI) within the range of 19.0-26.0 (including the critical value) (BMI = weight (kg) / height 2 (m2)), the weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg; 3. Those who had no birth plan within 2 weeks before screening and within 6 months after the end of the trial and agree to take effective non-drug contraceptive measures during the trial; 4. Understand and sign the informed consent form. Exclusion Criteria: 1. Persons with allergic constitutions, history of drug or food allergies, especially those who were allergic to any ingredient in this product and its excipients; 2. Individuals with a history of hypoglycemia; 3. Individuals deemed ineligible by the clinical research physician due to significant clinical abnormalities in medical history, physical examination, laboratory tests, and other related examinations; 4. Individuals with a history of smoking addiction within 12 months prior to screening (the number of cigarettes smoked ≥5 per day); 5. Individuals with a history of alcohol abuse within the past 12 months (consuming ≥14 units of alcohol weekly: 1 unit = 285 mL of beer, or 25 mL of spirits, or 150 mL of wine), or who tested positive for alcohol on breath tests prior to study enrollment (testing value \>0mg/100mL); 6. Individuals with a history of substance abuse within the past 12 months or who tested positive for addictive substances prior to enrollment; 7. Individuals who underwent surgery within the past 3 months, especially those who had had surgeries that would affect drug absorption, distribution, metabolism, or excretion, or those planning to undergo surgery during the study; 8. Individuals who had taken any medication that interacts with the trial drug in the 30 days prior to screening, such as strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, etc.); 9. Individuals with a history of cardiovascular, liver, kidney, pulmonary, gastrointestinal, neurological diseases, especially any surgical conditions or disorders that might affect drug absorption, distribution, metabolism, and excretion, or any surgical conditions or disorders that might pose hazards to participants; 10. Individuals with febrile illness within the 3 days prior to screening; 11. Individuals who had participated in any other clinical trials within the past 3 months; 12. Individuals with any history of prescription drugs, over-the-counter drugs, herbal medicine, or dietary supplements within 14 days prior to screening; 13. Individuals who had been vaccinated against the novel coronavirus within 14 days before screening or other vaccines within 3 months before screening or planed to be vaccinated during the trial; 14. Individuals who had consumed excessive tea, coffee, and/or caffeinated, xanthine, or alcoholic beverages (more than 8 cups, 1 cup = 250 mL) daily within the 3 months prior to screening; 15. Individuals who had lost blood or donated ≥200 mL within the past 8 weeks; 16. Pregnant or breastfeeding women; 17. Individuals who could not tolerate venipuncture or had a history of vasovagal syncope; 18. Individuals deemed unsuitable for this study by the investigator.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Tianjin People's Hospital
Tianjin, China
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