A Study to Evaluate the Safety and Effectiveness of Lenacapavir Together With Other Antiretroviral Medications in People Living With HIV (CALIBRATE)

Official Title: Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With Other Antiretroviral Agents in People Living With HIV (CALIBRATE)


The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207, a new type of HIV Medication) containing regimens in people living with HIV (PLWH).

Eligibility criteria:

Key Inclusion Criteria:

- Antiretroviral (ARV) naive with no use of any ARV within one month of screening
- Use of pre-exposure prophylaxis (PrEP) (any duration), post-exposure prophylaxis (PEP) (any duration), or HIV-1 treatment (< 10 days therapy total) > 1 month prior to screening is permitted
- HIV-1 RNA ≥ 200 copies/mL at screening
- CD4+ cell count ≥ 200 cells/microliter at screening

Key Exclusion Criteria:
- Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection

Contact Information

Kathy Watson