A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)
Public ClinicalTrials.gov record NCT05996471. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b Multicenter, Randomized, Open-Label Study Comparing the Efficacy, Safety, PK, and Tolerability of VH3810109, Administered Either Intravenously Or As A Subcutaneous Infusion With rHuPH20, in Combination With CAB LA to Standard of Care in Virologically Suppressed Adults Living With HIV
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in accordance with the dosing schedule in virologically suppressed, Antiretroviral therapy (ART)-experienced adult participants living with HIV. VH3810109 plus rHuPH20 plus Cabotegravir arm of the study has been discontinued based on preliminary results. The study will be conducted in 3 parts followed by a Long-Term Follow-up phase (LTFU).
Study identification
- NCT ID
- NCT05996471
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 185 participants
Conditions and interventions
Conditions
Interventions
- VH3810109 Biological
- Cabotegravir Drug
- Standard of care (SOC) Drug
- rHuPH20 Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 17, 2023 (Actual)
- Primary completion
- May 27, 2026 (Actual)
- Completion
- Nov 9, 2028 (Estimated)
- Last update posted
- Jul 29, 2026
2023 – 2028
United States locations
- U.S. sites
- 43
- U.S. states
- 20
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35222 | — |
| GSK Investigational Site | Bakersfield | California | 93309 | — |
| GSK Investigational Site | Los Angeles | California | 90027 | — |
| GSK Investigational Site | Los Angeles | California | 90069 | — |
| GSK Investigational Site | Palm Springs | California | 92262 | — |
| GSK Investigational Site | Sacramento | California | 95825 | — |
| GSK Investigational Site | San Francisco | California | 94110 | — |
| GSK Investigational Site | New Haven | Connecticut | 06510 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20037 | — |
| GSK Investigational Site | Fort Lauderdale | Florida | 33308 | — |
| GSK Investigational Site | Ft. Pierce | Florida | 34982 | — |
| GSK Investigational Site | Miami | Florida | 33133 | — |
| GSK Investigational Site | Orlando | Florida | 32803 | — |
| GSK Investigational Site | Pensacola | Florida | 32503 | — |
| GSK Investigational Site | Sarasota | Florida | 34237 | — |
| GSK Investigational Site | Vero Beach | Florida | 32960 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33409 | — |
| GSK Investigational Site | Decatur | Georgia | 30033 | — |
| GSK Investigational Site | Chicago | Illinois | 60611 | — |
| GSK Investigational Site | Boston | Massachusetts | 02115 | — |
| GSK Investigational Site | Springfield | Massachusetts | 01105 | — |
| GSK Investigational Site | Southfield | Michigan | 48075 | — |
| GSK Investigational Site | Columbia | Missouri | 65212 | — |
| GSK Investigational Site | Newark | New Jersey | 07102 | — |
| GSK Investigational Site | Albuquerque | New Mexico | 87109 | — |
| GSK Investigational Site | Santa Fe | New Mexico | 87505 | — |
| GSK Investigational Site | Manhasset | New York | 11030 | — |
| GSK Investigational Site | New York | New York | 10029 | — |
| GSK Investigational Site | New York | New York | 10032 | — |
| GSK Investigational Site | New York | New York | 10461 | — |
| GSK Investigational Site | The Bronx | New York | 10467 | — |
| GSK Investigational Site | Greensboro | North Carolina | 27401-1209 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45267 | — |
| GSK Investigational Site | Portland | Oregon | 97239 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | — |
| GSK Investigational Site | Nashville | Tennessee | 37208 | — |
| GSK Investigational Site | Austin | Texas | 78705 | — |
| GSK Investigational Site | Dallas | Texas | 75246 | — |
| GSK Investigational Site | El Paso | Texas | 79902 | — |
| GSK Investigational Site | Houston | Texas | 77030 | — |
| GSK Investigational Site | Houston | Texas | 77098 | — |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05996471, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05996471 live on ClinicalTrials.gov.