NCT03001128 is a clinical trial of Antiretroviral treatment pause in HIV-1 Infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

What drugs are being tested in NCT03001128?

Interventions in NCT03001128: Antiretroviral treatment pause.

What condition does NCT03001128 study?

NCT03001128 studies HIV-1 Infection.

Is NCT03001128 still recruiting?

NCT03001128 is currently completed. Last updated 13 December 2024.

Last reviewed 2024-12-13 · How we verify

NCT03001128

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Biomarkers to Predict Time to Plasma HIV RNA Rebound

Completed Last updated 13 December 2024

What this trial tests

trial testing Antiretroviral treatment pause in HIV-1 Infection in 61 participants. Completed in 29 January 2021.

Timeline

23 February 2017

Primary endpoint
29 January 2021

29 January 2021

Quick facts

Lead sponsor	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Status	Completed
Study type	OBSERVATIONAL
Enrollment	61
Start date	23 February 2017
Primary completion	29 January 2021
Estimated completion	29 January 2021
Sites	18 locations across Thailand, Puerto Rico, United States

Drugs / interventions tested

Antiretroviral treatment pause — full drug profile →

Conditions studied

HIV-1 Infection — all drugs for HIV-1 Infection →

Sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Who can join

Adults 18 to 70, any sex, with HIV-1 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to collect information about what happens when people pause, or temporarily stop taking, ART, and to collect blood samples from these people at frequent intervals. We will also study the safety of pausing ART under close observation.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Predictors of HIV rebound differ by timing of antiretroviral therapy initiation.
Li JZ, Melberg M, Kittilson A, Abdel-Mohsen M, et al · · 2024 · cited 27× · PMID 38329130 · DOI 10.1172/jci.insight.173864
How to Address the Risk of HIV Transmission in Remission Studies With Treatment Interruption: The Low-Hanging Fruit Approach.
Eyal N. · · 2019 · cited 13× · PMID 31264692 · DOI 10.1093/infdis/jiz163
Participant Perspectives and Experiences Following an Intensively Monitored Antiretroviral Pause in the United States: Results from the AIDS Clinical Trials Group A5345 Biomarker Study.
Dubé K, Eskaf S, Barr L, Palm D, et al · · 2022 · cited 11× · PMID 35323030 · DOI 10.1089/aid.2021.0170
Participant Perspectives and Experiences Entering an Intensively Monitored Antiretroviral Pause: Results from the AIDS Clinical Trials Group A5345 Biomarker Study.
Diepstra KL, Barr L, Palm D, Hogg E, et al · · 2021 · cited 11× · PMID 33472545 · DOI 10.1089/aid.2020.0222
Viral and Immune Risk Factors of HIV Rebound After Interruption of Antiretroviral Therapy.
Gianella S, Yu T, Wang R, Ignacio C, et al · · 2025 · cited 1× · PMID 39661441 · DOI 10.1093/infdis/jiae585
Characterization of HIV humoral immunity during analytical treatment interruption.
Di Germanio C, Balasko BG, Villaflor PG, Noutsios G, et al · · 2026 · PMID 41791199 · DOI 10.1016/j.jcv.2026.105930

Verify or expand the search:

Other recruiting trials for HIV-1 Infection

Currently open trials in the same condition.

NCT06660498 — Pomalidomide as an Immune-enhancing Agent for the Control of HIV · Phase 1, PHASE2 · recruiting
NCT06602622 — Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI · Phase 4 · recruiting
NCT05705349 — DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053) · Phase 3 · active not recruiting
NCT05631093 — A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Vir · Phase 3 · active not recruiting
NCT05630755 — A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Vir · Phase 3 · active not recruiting

Other Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections trials

Trials by the same sponsor.

NCT06205589 — Therapeutic ID93 + GLA-SE Vaccination in Participants With Rifampicin-Susceptible Pulmonary TB · Phase 2 · not yet recruiting
NCT06856174 — Menopausal HT for Women Living With HIV (HoT) · Phase 4 · not yet recruiting
NCT06205602 — Antiretrovirals Combined With Antibodies for HIV-1 Cure In Africa · Phase 2 · recruiting
NCT06031272 — Pausing Antiretroviral Treatment Under Structured Evaluation · Phase 1 · active not recruiting
NCT05985642 — Observational PIC Destination Cohort · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03001128 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Last refreshed: 13 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03001128.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing