CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 138 enrolled
Drug / intervention
Cabotegravir sodium (Oral Lead In) +7 moredrug
Likely dose
Cabotegravir 400 mg/mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04484337
NCT04484337Phase 1Completed
CompareCT.gov

A Phase 1, Two-part, Double-blind, Active-control, Randomized Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Repeat-Dose Cabotegravir (CAB 400 mg/mL Formulation) Long-Acting Injection Following Subcutaneous or Intramuscular Administration in Healthy Adult Participants

ViiV Healthcare·interventional·Posted Jul 23, 2020·Updated May 29, 2026

In Brief

A Phase 1 clinical trial evaluating Cabotegravir sodium (Oral Lead In), Cabotegravir 400 mg/mL, and 6 other interventions for HIV Infections. Completed, enrolled 138 participants across 5 sites in 2 countries.

Detailed Summary

This is an active control, randomized study to investigate the safety, tolerability and PK of repeat dose administration of long-acting CAB 400 mg/mL formulation intramuscular (IM) (gluteus medius and vastus lateralis) and subcutaneous (SC) (abdominal) injections in healthy adult participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesNew Zealand, United States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJul 23, 2020
Enrollment StartJul 31, 2020
Primary CompletionMay 5, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.9 years ago

Interventions

Cabotegravir sodium (Oral Lead In)drug

CAB 30 mg tablets administered orally.

Cabotegravir 400 mg/mLdrug

CAB 400 mg/mL administered intramascularly or subcutaneously.

Cabotegravir 200 mg/mLdrug

CAB 200 mg/mL administered intramascularly or subcutaneously.

Topical Non-steroidal anti-inflammatory drug (NSAID)drug

NSAID applied topically.

Topical steroiddrug

Steroid medication applied topically.

Topical NSAID placebodrug

Placebo for NSAID applied topically.

Recombinant human hyaluronidase PH20 (rHuPH20)drug

rHuPH20 administered subcutaneously.

Topical steroid placebodrug

Placebo for steroid applied topically.