Trial comparing treatments for HIV Infections
Official title Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
ClinicalTrials.gov ID: NCT07682961
What this study is testing
What is Lenacapavir?
Lenacapavir is an investigational medicine, given as a once-daily injection under the skin, being studied as a potential treatment for hiv infections.
Also referred to as LEN.
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 aims to see if a new combination of three injections is just as effective as a standard two-injection treatment for keeping HIV under control.
- Who it's for
- Adults with HIV whose virus is currently well-controlled by taking daily pills.
- What's involved
- Participants will switch from daily pills to either the new three-injection treatment or the standard two-injection treatment, given every 8 weeks.
- Time commitment
- The study lasts one year and requires regular visits to receive injections and check blood levels.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria: 1) Proviral phenotypic susceptibility to...
- At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening.
- A plasma HIV-1 RNA test \ 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be \< 50 copies/mL...
- On a stable oral ARV therapy (ART) for ≥ 6 months prior to screening.
- A change in ART regimen ≥ 3 months prior to the screening visit for reasons other than virologic failure (VF) (eg, side effects, simplification...
You likely can't join if
- History of an opportunistic infection or illness indicative of Stage 3 HIV disease.
- History of treatment failure.
- Known or suspected resistance to either CAB or RPV.
- Resistance to CAB defined as the following mutations: G118R, Q148K, Q148R, T66K+L74M, E92Q+N155H, E138A+Q148R, E138K+Q148K/R, G140C+Q148R...
- Resistance to RPV defined as the following mutations: K101E and P; E138A, G, K, R, and Q; V179L; Y181C, I, and V; Y188L; H221Y; F227C
- Individuals with a dermatologic condition or implanted prothesis overlying the gluteal injection site for CAB + RPV.
See the full eligibility criteria
- Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria: 1) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at...
- At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening.
- A plasma HIV-1 RNA test \ 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be \< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the...
- On a stable oral ARV therapy (ART) for ≥ 6 months prior to screening.
- A change in ART regimen ≥ 3 months prior to the screening visit for reasons other than virologic failure (VF) (eg, side effects, simplification, drug-drug interaction profile) is allowed
- History of an opportunistic infection or illness indicative of Stage 3 HIV disease.
- History of treatment failure.
- Known or suspected resistance to either CAB or RPV.
- Resistance to CAB defined as the following mutations: G118R, Q148K, Q148R, T66K+L74M, E92Q+N155H, E138A+Q148R, E138K+Q148K/R, G140C+Q148R, G140S+Q148H/K/R, Y143H+N155H, and Q148R+N155H.
- Resistance to RPV defined as the following mutations: K101E and P; E138A, G, K, R, and Q; V179L; Y181C, I, and V; Y188L; H221Y; F227C; M230I and L, and the combination of L100I/K103N.
- Individuals with a dermatologic condition or implanted prothesis overlying the gluteal injection site for CAB + RPV.
- Known hypersensitivity to the study intervention, its metabolites, or formulation excipients.
- Active, serious infections (other than HIV-1) requiring therapy \< 30 days prior to randomization.
- Active tuberculosis infection.
- Acute hepatitis of any cause \< 30 days before randomization.
- History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C).
- Active malignancy requiring acute systemic therapy.
- Have poor venous access that would limit phlebotomy or intravenous (IV) infusion of study drugs.
- Prior use of, or exposure to, LEN or a broadly neutralizing antibody (bNAb) for HIV-1.
- Prior use of, or exposure to, long-acting (LA) injectable CAB or LA injectable RPV.
- Prior use of, or exposure to, ibalizumab, fostemsavir, or maraviroc.
- Baseline regimen consisting of monotherapy with any single antiretroviral (ARV).
- Treatment with immunosuppressant therapies (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) within 4 weeks of screening (with the exception of a single short course of...
- Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.
- Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.
- Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
- Severe renal impairment-estimated glomerular filtration rate \< 30 mL/min according to the Cockcroft-Gault formula.
- Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant, as determined by the investigator.
- Alanine aminotransferase \> 5 x upper limit of normal (ULN).
- Direct bilirubin \> 1.5 x ULN.
- Platelets \< 50,000/mm\^3.
- Hemoglobin \< 8.0 g/dL. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- DeLand, Florida, United States
- Fort Lauderdale, Florida, United States
- Ft. Pierce, Florida, United States
- Miami Gardens, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
- Berkley, Michigan, United States
- Kansas City, Missouri, United States
- Dallas, Texas, United States
- Annandale, Virginia, United States
- Seattle, Washington, United States
- Surry Hills, New South Wales, Australia
- Sydney, New South Wales, Australia
- Osaka, Japan
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States; DeLand, Florida, United States; Fort Lauderdale, Florida, United States; Ft. Pierce, Florida, United States; Miami Gardens, Florida, United States; Orlando, Florida, United States and 12 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.