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Phase 1 N=49 Treatment

Study of Novel Antiretrovirals in Participants With HIV-1

HIV-1-infection

Enrolled (actual)
49
Serious AEs
4.1%
Results posted
May 2025
Primary outcome: Primary: Substudies 01, 02 and 03: Change From Baseline in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (log10 Copies/mL) at Day 11 Relative to Historical Placebo Data — 4.68; 4.68; 4.27; 5.16 log10 copies/mL — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Bavtavirine (Drug); B/F/TAF (Drug); Standard of Care (Substudy 01) (Drug); GS-1720 (Drug); Standard of Care (Substudy 02) (Drug); GS-6212 (Drug); Standard of Care (Substudy 03) (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Gilead Sciences
Primary completion
Feb 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Substudies 01, 02 and 03: Change From Baseline in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (log10 Copies/mL) at Day 11 Relative to Historical Placebo Data
4.68; 4.68; 4.27; 5.16; 4.72; 4.52 <0.0001 sig
SECONDARY
Substudies 01, 02 and 03: Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Day 8 Relative to Historical Placebo Data
4.68; 4.68; 4.27; 5.16; 4.72; 4.52 <0.0001 sig
SECONDARY
Substudies 01, 02 and 03: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
50.0; 16.7; 100; 42.9; 85.7; 85.7
SECONDARY
Substudies 01, 02 and 03: Percentage of Participants With Graded Laboratory Abnormalities
100; 100; 100; 100; 100; 100
SECONDARY
Substudy 01: Pharmacokinetic (PK) Parameter: Cmax of Bavtavirine
685; 700; 565; 1160
SECONDARY
Substudy 01: PK Parameter: AUC of Bavtavirine
33,300; 24,300; 71,400; 38,800; 28,300; 89,100
SECONDARY
Substudy 01: PK Parameter: Plasma Concentration of Bavtavirine
94.5; 64.8; 250; 61.2; 44.6; 202
SECONDARY
Substudy 02: PK Parameter: Cmax of GS-1720
17.2; 9.77; 3.00; 33.7; 30.8; 15.6
SECONDARY
Substudy 02: PK Parameter: AUC of GS-1720
2790; 1670; 503; 4960; 3540; 2160
SECONDARY
Substudy 02: PK Parameter: Plasma Concentration of GS-1720
12.2; 7.44; 2.59; 22.7; 8.78; 5.87
SECONDARY
Substudy 03: PK Parameter: Cmax of GS-6212
1590; 1550
SECONDARY
Substudy 03: PK Parameter: AUC0-8h of GS-6212
5030; 5700
SECONDARY
Substudy 03: PK Parameter: AUCtau of GS-6212
6450
SECONDARY
Substudy 03: PK Parameter: Plasma Concentration of GS-6212
221; 260
SECONDARY
Substudy 03: PK Parameter: Ctrough of GS-6212 (Day 10)
140
SECONDARY
Substudy 03: PK Parameter: Cavg of GS-6212 (Day 10)
538
SECONDARY
Substudies 01, 02 and 03: Percentage of Participants at Any Measurement Achieving HIV-1 RNA < 50 Copies/mL by Day 11 at Each Dose Level
0; 0; 0; 0; 0; 28.6
SECONDARY
Substudies 01, 02 and 03: Percentage of Participants With Emergence of Viral Resistance to the ARV Class of the Given Drug
33.0; 16.6; 0; 0; 0; 0
SECONDARY
Substudy 01: Maximum Inhibitory Quotient (IQ) of Bavtavirine by Mean Plasma Concentration (Ct) up to Day 11
5; 5; 5
SECONDARY
Substudy 02: Inhibitory Quotient (IQ) of GS-1720 by Mean Plasma Concentration (Ct) at Day 11
4.5; 3; 0.8; 9.5
SECONDARY
Substudy 03: Inhibitory Quotient (IQ) of GS-6212 by Ctrough at Day 11
6.5

Summary

Master protocol: The goal of this master clinical trial study is to learn how novel antiretrovirals (medicines that stop the virus from multiplying) affect the human immunodeficiency virus-1 (HIV-1) infection in people living with HIV (PWH). Substudy-01 (GS-US-544-5905-01) will evaluate bavtavirine in PWH. Substudy-02 (GS-US-544-5905-02) will evaluate GS-1720 in PWH. Substudy-03 (GS-US-544-5905-03) will evaluate GS-6212 in PWH.

Eligibility Criteria

Key Inclusion Criteria

All Substudies:

  • Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 5000 copies/mL but ≤ 400,000 copies/mL at screening.
  • Cluster of differentiation 4 (CD4) cell count > 200 cells/mm^3 at screening.
  • Antiretroviral (ARV) treatment-naive or treatment-experienced but naive to the investigational ARV drug class being investigated in the given substudy and have not received any ARV within 12 weeks of screening, including medications received for pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) (note that current or prior receipt of long acting (LA) parenteral ARVs such as monoclonal antibodies (mAbs) targeting HIV-1, injectable cabotegravir (CAB), or injectable rilpivirine (RPV) is exclusionary).
  • Have adequate renal function (estimated glomerular filtration rate (eGFR) ≥ 70 mL/min/1.73 m^2)
  • No clinically significant abnormalities in electrocardiogram (ECG) at screening.

Substudy-01, Substudy-02, and Substudy-03:

  • Participants in substudy-01 should be willing to initiate a non-NNRTI based SOC ART on Day 11.
  • Participants in substudy-02 and Substudy-03 should be willing to initiate any SOC ART on Day 11.
  • Willing and able to comply with meal requirements on dosing days.

Key Exclusion Criteria

All Substudies:

  • Known historical genotypic or phenotypic resistance to 4 major ARV classes (nucleoside reverse transcriptase inhibitor (NRTI), nonnucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI), integrase strand-transfer inhibitor (INSTI)).
  • History of an AIDS-defining condition including present at the time of screening.
  • Active, serious infections (other than HIV-1) requiring therapy and including active tuberculosis infection 5 x upper limit of normal (ULN).
  • Current alcohol or substance use judged by the investigator to potentially interfere with individual study compliance.
  • Positive serum pregnancy test at screening or a positive pregnancy test prior to Day 1.
  • Individuals with plan to breastfeed during the study period including the protocol-defined follow-up period.
  • Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol. Any prescription medications or over the counter medications, including herbal products, within 28 days prior to start of study drug dosing must be reviewed and approved by the sponsor, with the exception of vitamins and/or acetaminophen and/or ibuprofen.
  • Any current or prior receipt of LA parenteral ARVs such as mAbs targeting HIV-1, injectable CAB, or injectable RPV, for treatment or prophylaxis (PrEP, PEP).

Substudy-01, Substudy-02, Substudy-03:

  • Requirement for ongoing therapy with any prohibited medications listed in protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05585307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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