Clinical trial for Acute HIV Infection
Official title A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission
ClinicalTrials.gov ID: NCT05719441
What this study is testing
What is VRC07-523LS?
An investigational intravenous antibody being studied for acute HIV 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
- The study wants to see if giving a mix of HIV‑specific antibodies along with standard HIV medicine during the first weeks of infection is safe and can delay the virus from rising after stopping treatment. It also looks at whether the antibodies reduce the hidden virus and boost the immune response.
- Who it's for
- Adults who have just been diagnosed with HIV and have not yet started HIV medicine.
- What's involved
- Participants will receive either the antibody mix or a placebo, plus the usual HIV medicine. They will have regular clinic visits, blood tests, and a planned pause in treatment to see how the virus behaves.
- Time commitment
- The study lasts about 12 months, with frequent visits during the first few months and additional visits during the treatment pause and follow‑up.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 70
You may be able to join if
- Between 18 and 70 years of age
- Body weight under 115 kg (approximately 253 pounds)
- Evidence of recently acquiring HIV
- Not pregnant or breastfeeding
- No recent use of medications to prevent or treat HIV
See the full eligibility criteria
- Between 18 and 70 years of age
- Body weight under 115 kg (approximately 253 pounds)
- Evidence of recently acquiring HIV
- Not pregnant or breastfeeding
- No recent use of medications to prevent or treat HIV
- Able and willing to provide informed consent to study and its procedures which include
- initiating HIV medications (also called antiretroviral treatment or ART) following enrollment,
- A later, monitored pause in HIV medications (also called an analytical treatment interruption, or ATI)
- While pausing HIV treatment per study guidelines until resuppressed following treatment restart, agree to using barrier contraception to prevent HIV acquisition in sexual partners
- Agree to use effective contraception to prevent pregnancy in oneself and sexual partners who may become pregnant.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Porto Alegre, Brazil
- Rio de Janeiro, Brazil
- Lima, Peru
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, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States and 5 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.