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New treatment option for HIV-1 Infection
Official title A Phase Ⅱa Clinical Study of CL-197 Capsules
ClinicalTrials.gov ID: NCT07308782
What this study is testing
What is CL-197 capsules?
CL-197 capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hiv-1 infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the antiretroviral activity, safety and pharmacokinetics of single dose of CL-197 capsule in three dose groups administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Participants aged 18-60 (including boundary values), both male and female.
- Body mass index (BMI) range between 18.5-29.9 (including the boundary value). Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women.
- Participants diagnosed with HIV-1 infection before screening, and never received any anti-HIV drugs or HIV-related vaccine therapy (including...
- Participants who agree not to receive other anti-HIV drugs during the trial period (from signing the informed consent form until the Day 13 sampling).
- CD4 cell count \> 200 cells/μL at screening.
You likely can't join if
- Diagnosis of acute HIV-1 infection, or presence of an AIDS-defining disease at enrollment, or history of an opportunistic infection within 3 months...
- Had pre-exposure prophylaxis (PrEP) and/or post-exposure prophylaxis (PEP) treatment within 1 month prior to screening.
- Had any clinically significant disease (including cardiovascular, respiratory, digestive, endocrine/metabolic, neurological/psychiatric...
- Resting systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, or heart rate \> 100 beats per minute, or heart rate \ 450 ms...
- History of severe allergy (immediate, life-threatening systemic anaphylaxis) to drugs (e.g., aspirin or cephalosporin antibiotics), other drug...
- Had major gastrointestinal surgery within 6 months prior to screening (except uncomplicated appendectomy or cholecystectomy), or any surgery that...
See the full eligibility criteria
Who can join
- Participants aged 18-60 (including boundary values), both male and female.
- Body mass index (BMI) range between 18.5-29.9 (including the boundary value). Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women.
- Participants diagnosed with HIV-1 infection before screening, and never received any anti-HIV drugs or HIV-related vaccine therapy (including investigational or other unmarketed anti-HIV drugs or vaccines) before...
- Participants who agree not to receive other anti-HIV drugs during the trial period (from signing the informed consent form until the Day 13 sampling).
- CD4 cell count \> 200 cells/μL at screening.
- Women of childbearing potential (WOCBP) must have adopted effective non-drug contraceptive measures, have a negative serum pregnancy test at screening/baseline, and be willing to use appropriate effective methods of...
- Participants who understand and sign the informed consent form.
What rules you out
- Diagnosis of acute HIV-1 infection, or presence of an AIDS-defining disease at enrollment, or history of an opportunistic infection within 3 months prior to enrollment with the condition remaining unstable within 4...
- Had pre-exposure prophylaxis (PrEP) and/or post-exposure prophylaxis (PEP) treatment within 1 month prior to screening.
- Had any clinically significant disease (including cardiovascular, respiratory, digestive, endocrine/metabolic, neurological/psychiatric, hematological, and immune system diseases, etc.) that is poorly controlled, as...
- Resting systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, or heart rate \> 100 beats per minute, or heart rate \ 450 ms, or fasting blood glucose ≥ 7.0 mmol/L.
- History of severe allergy (immediate, life-threatening systemic anaphylaxis) to drugs (e.g., aspirin or cephalosporin antibiotics), other drug components (e.g., lactose or gelatin), or food, or history of allergic...
- Had major gastrointestinal surgery within 6 months prior to screening (except uncomplicated appendectomy or cholecystectomy), or any surgery that could affect drug absorption, distribution, metabolism and excretion; or...
- History of malignancy (except carcinoma in situ of the cervix treated with conization, or radically resected basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ [Bowen's disease] of the skin).
- Hepatitis B surface antigen (HBsAg) positive at screening, or active syphilis, or Hepatitis C virus (HCV) antibody positive, or previous interferon treatment for HBV infection leading to HBsAg seroconversion.
- Hemoglobin (Hb) \< 110 g/L, or white blood cell (WBC) count \< 3 × 10\^9/L, or absolute neutrophil count (ANC) \< 1 × 10\^9/L, or platelet (PLT) count \< 100 × 10\^9/L at screening.
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2.5 times upper limit of normal (ULN), or total bilirubin (TBIL) ≥ 1.5 × ULN at screening.
- Serum creatinine (SCr) \> 1.1 × ULN, or creatinine clearance (Ccr) \< 60 mL/min (calculated by Cockcroft-Gault formula) at screening.
- Participants smoke more than 5 cigarettes daily on average within 3 months prior to screening, or may be unwilling to stop using any tobacco products during drug administration and sampling periods.
- Drinking more than 14 units of alcohol (1 unit of alcohol ≈ 360 mL of beer with 5% alcohol, or 45 mL of liquor with 40% alcohol, or 150 mL of wine with 12% alcohol) within 3 months prior to screening on average, or...
- Excessive consumption of tea, coffee, and/or caffeine-containing beverages (averaging more than 8 cups per day, 1 cup ≈ 250 mL) within 3 months prior to screening on average, or unwillingness to stop consuming tea...
- Participants with consumption of pitaya, mango, pomelo, carambola, or foods/beverages prepared from them, or foods/beverages containing xanthine, caffeine, or alcohol (including chocolate, tea, coffee, cola, cocoa...
- History of drug abuse (non-medical, excessive, misuse, or addictive use of any drug leading to social, psychological, or physical impairment) within 5 years prior to screening, or positive urine drug screen at screening...
- Intolerance to venipuncture, or history of needle or blood phobia, or blood donation (including component blood) or significant blood loss (≥400 mL) or blood transfusion within 3 months prior to screening, or blood...
- Specific dietary requirements during the trial, or inability to accept the standardized diet.
- Have participated in or are participating in other investigational drug or treatment medical device clinical trials (having signed informed consent and received investigational drug/treatment device or placebo) within 3...
- Pregnant or breastfeeding females at screening, or positive serum pregnancy test (applicable to WOCBP only).
- Have a birth plan (including egg or sperm donation) by WOCBP or male participants from 1 month prior to informed consent until 3 months after administration of the investigational drug, or unwillingness to use effective...
- Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products within 14 days prior to dosing.
- Any other conditions considered by the investigator as unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.