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New treatment option for HIV-1-infection
Official title Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
ClinicalTrials.gov ID: NCT06749054
What this study is testing
What is Oral Lenacapavir?
Oral Lenacapavir is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hiv-1-infection.
Also referred to as GS-6207, Sunlenca®.
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
- The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1.
- 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 up to 17
You may be able to join if
- Body weight at screening ≥ 35 kg.
- On a stable failing antiretroviral (ARV) regimen for \> 8 weeks before screening and willing to continue the regimen until Day 1.
- Plasma HIV-1 RNA ≥ 400 copies/mL on at least 2 consecutive occasions spanning at least 6 months, including at screening.
- Have previously changed their ARV regimen due to treatment failure.
- ARV treatment options limited due to resistance, side effects, contraindications, safety, drug access.
You likely can't join if
- Life expectancy ≤ 1 year.
- An opportunistic illness requiring treatment within the 30 days prior to screening.
- Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months prior to screening.
- Hepatitis C virus (HCV) antibody positive with detectable HCV RNA at screening.
- Hepatitis B virus (HBV) surface antigen (HBsAg) positive or HBV core antibody (antibody against hepatitis B core antigen (anti-HBc)) positive; if...
See the full eligibility criteria
- Body weight at screening ≥ 35 kg.
- On a stable failing antiretroviral (ARV) regimen for \> 8 weeks before screening and willing to continue the regimen until Day 1.
- Plasma HIV-1 RNA ≥ 400 copies/mL on at least 2 consecutive occasions spanning at least 6 months, including at screening.
- Have previously changed their ARV regimen due to treatment failure.
- ARV treatment options limited due to resistance, side effects, contraindications, safety, drug access.
- Able and willing to commit to taking LEN in combination with their OBR.
- The following laboratory parameters at screening:
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m\^2 using Bedside Schwartz Formula.
- Absolute neutrophil count \> 0.50 GI/L (\> 500 cells/mm\^3).
- Hemoglobin ≥ 85 g/L (\> 8.5 g/dL).
- Platelets ≥ 50 GI/L (≥ 50,000/mm\^3).
- Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 × upper limit of normal.
- Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL). Key
- Life expectancy ≤ 1 year.
- An opportunistic illness requiring treatment within the 30 days prior to screening.
- Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months prior to screening.
- Hepatitis C virus (HCV) antibody positive with detectable HCV RNA at screening.
- Hepatitis B virus (HBV) surface antigen (HBsAg) positive or HBV core antibody (antibody against hepatitis B core antigen (anti-HBc)) positive; if individual is HBsAg negative and anti-HBc positive but HBV DNA...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Cape Town, South Africa
- Germiston, South Africa
- Johannesburg, South Africa
- KwaDukuza, South Africa
- KwaZulu - Natal, South Africa
- Paarl, South Africa
- Soweto, South Africa
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, up to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Cape Town, South Africa; Germiston, South Africa; Johannesburg, South Africa; KwaDukuza, South Africa; KwaZulu - Natal, South Africa and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.