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New treatment option for HIV
Official title Exploratory Study of LP-98 for Injection in ART-Naive HIV-Infected Individuals
ClinicalTrials.gov ID: NCT07433387
What this study is testing
What is LP-98 20 mg?
LP-98 20 mg is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hiv.
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
- An Exploratory Multicenter, Open-label, Sequential Cohort Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacokinetic Characteristics of LP-98 for Injection in Antiretroviral Therapy-Naive HIV-Infected Individuals
- Phase 2: a mid-size study of how well it works
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 65
You may be able to join if
- The subject must voluntarily agree to participate in the study and provide informed consent before undergoing any study-related assessments.
- At the time of screening, the subject must be between 18 and 65 years of age (inclusive), either male or female.
- At the time of screening, male people must weigh at least 50 kg, and female people must weigh at least 45 kg.
- Plasma HIV RNA levels must be ≥1000 copies/mL, and CD4+ T lymphocyte count must be ≥200 cells/μL.
- For Female people: Only non-reproductive females will be included, which includes those who have undergone surgical sterilization (documented...
You likely can't join if
- Known allergy to the study drug or its excipients, or a history of severe allergic reactions (including any food allergies or drug allergies).
- Has previously received antiviral therapy (ART) or has been vaccinated against HIV.
- A history of severe disease or the presence of other severe chronic conditions.
- A history of mental health disorders or a family history of psychiatric diseases.
- Any of the Following Conditions: 1）Persistent unexplained fever above 38°C within 1 month prior to screening or during the screening phase...
See the full eligibility criteria
- The subject must voluntarily agree to participate in the study and provide informed consent before undergoing any study-related assessments.
- At the time of screening, the subject must be between 18 and 65 years of age (inclusive), either male or female.
- At the time of screening, male people must weigh at least 50 kg, and female people must weigh at least 45 kg.
- Plasma HIV RNA levels must be ≥1000 copies/mL, and CD4+ T lymphocyte count must be ≥200 cells/μL.
- For Female people: Only non-reproductive females will be included, which includes those who have undergone surgical sterilization (documented hysterectomy or bilateral oophorectomy) at least 6 weeks prior to the...
- For Male people with Fertile Female Partners: The subject must agree to use a non-pharmacological contraception method for 14 days prior to dosing, during the study, and for 3 months following the administration of the...
- The subject must be willing to adhere to the study protocol, including visits, study treatment, laboratory tests, and other study-related procedures and requirements.
- Known allergy to the study drug or its excipients, or a history of severe allergic reactions (including any food allergies or drug allergies).
- Has previously received antiviral therapy (ART) or has been vaccinated against HIV.
- A history of severe disease or the presence of other severe chronic conditions.
- A history of mental health disorders or a family history of psychiatric diseases.
- Any of the Following Conditions: 1）Persistent unexplained fever above 38°C within 1 month prior to screening or during the screening phase. 2）Persistent diarrhea (more than 3 bowel movements per day) within 1 month...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, 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.