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)

Purpose:

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
614-293-8112New
kathy.watson@osumc.edu

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