Clinical Trials Logo

Clinical Trial Summary

Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV infection is considered to be a chronic disease requiring lifelong therapy. This study will evaluate how safe ABBV-382 is and how it is absorbed, distributed and eliminated from the body in adult participants with HIV-1 infection. ABBV-382 is an investigational drug being developed for the treatment of HIV-1 infection. This study takes place in 2 parts. In Part A, participants with HIV-1 and no history of combination antiretroviral therapy (cART) or who are off cART for more than 3 months will be enrolled to receive ABBV-382. In Part B, participants with no virus in their blood and on maintenance cART will be enrolled into one of the intravenous (IV) or subcutaneous (SC) groups. In the IV groups, participants will receive either placebo or ABBV-382 whereas participants in the SC group will receive ABBV-382. There is 1 in 3 chance that participants will receive placebo (no drug) in Part B IV groups. The IV group in Part B is double-blinded which means neither the study doctors nor the participants will know who will be given study drug or placebo. Around 52 adult participants with HIV-1 infection will be enrolled at approximately 21 sites across the United States, including Puerto Rico. Participants in Part A will receive an intravenous (IV) dose of ABBV-382 on Day 1. Participants in Part B will receive an IV or SC dose of ABBV-382 or placebo on Days 1, 29 and 57. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and presence of side effects.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04554966
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 1
Start date April 16, 2021
Completion date August 14, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT02511496 - Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia N/A
Completed NCT02234492 - The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients Phase 4
Completed NCT01685372 - Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults Phase 2
Completed NCT02027441 - Enhanced Prevention in Couples: Feasibility Study #2 N/A
Completed NCT02165202 - Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis Phase 2
Terminated NCT01448486 - A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV Phase 4
Completed NCT01449006 - A Study of the Neurological Effects of Adding Maraviroc to HAART Regimen in Patients With HIV (HANDmac) Phase 4
Completed NCT02572401 - Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men N/A
Completed NCT01615601 - An Observational Study to Evaluate Tolerability of PREZISTA or INTELENCE in HIV-1 Infected Patients Phase 4
Completed NCT04122404 - POC Strategies to Improve TB Care in Advanced HIV Disease N/A
Completed NCT03290755 - Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux
Completed NCT02974998 - Cape Town Young Women's Health CoOp N/A
Completed NCT01997346 - Multi-level Determinants of Starting ART Late: Aim 2 N/A
Completed NCT01516970 - Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r) Phase 3
Active, not recruiting NCT01875952 - Diagnosis and Treatment of Co-infection With Human Immunodeficiency Virus /Latent Tuberculosis Infection (HIV/TBL) Phase 4
Completed NCT01199939 - A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients Phase 2
Completed NCT03783130 - Dose, Safety, Tolerability, and Immunogenicity of an HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults Phase 1
Active, not recruiting NCT05657106 - Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk N/A
Not yet recruiting NCT05727033 - Extraordinarily Fun Training Project in Compulsory Secondary Education - Sexually Transmitted Infections N/A
Completed NCT01053741 - Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission N/A