Who is sponsoring NCT00491556?

NCT00491556 is sponsored by University of North Carolina, Chapel Hill.

What drugs are being tested in NCT00491556?

Interventions in NCT00491556: Early Initiation of Highly Active Anti-Retroviral Therapy, Standard Care.

What condition does NCT00491556 study?

NCT00491556 studies HIV Infections.

Is NCT00491556 still recruiting?

NCT00491556 is currently completed. Last updated 27 February 2017.

Are results published for NCT00491556?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-02-27 · How we verify

NCT00491556

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

Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r) in Adolescents With CD4 + T Cells > 350 Cells/mm3 Initiating HAART

Completed NA Results posted Last updated 27 February 2017

What this trial tests

NA trial testing Early Initiation of Highly Active Anti-Retroviral Therapy in HIV Infections in 102 participants. Completed in 1 June 2013.

Timeline

1 October 2007

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	1 October 2007
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	23 locations across United States, Puerto Rico

Drugs / interventions tested

Early Initiation of Highly Active Anti-Retroviral Therapy
Standard Care — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 18 to 24, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Difference in CD4+ T Cell Percentage Between Week 0 and Week 48
Time frame: Week 0 and Week 48
Difference in CD4+ T Cell Percentage Between Week 48 and Week 152
Time frame: 152 Weeks

Sponsor's own description

This study proposes to evaluate a pre-DHHS guideline of HAART initiation and then de-intensification management strategy in adolescents with mild immunosuppression and compare changes in CD4% from baseline to week 48 and then during de-intensification.

Publications & conference data

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

Optimal time for initiation of antiretroviral therapy in asymptomatic, HIV-infected, treatment-naive adults.
Siegfried N, Uthman OA, Rutherford GW. · · 2010 · cited 62× · PMID 20238364 · DOI 10.1002/14651858.cd008272.pub2
Analysis of data dictionary formats of HIV clinical trials.
Mayer CS, Williams N, Huser V. · · 2020 · cited 8× · PMID 33017454 · DOI 10.1371/journal.pone.0240047
Tenofovir Has Minimal Effect on Biomarkers of Bone Health in Youth with HIV Receiving Initial Antiretroviral Therapy.
Kim-Chang JJ, Wilson L, Chan C, Fischer B, et al · · 2019 · cited 5× · PMID 31115244 · DOI 10.1089/aid.2018.0270
Youth Who Control HIV on Antiretroviral Therapy Display Unique Plasma Biomarkers and Cellular Transcriptome Profiles Including DNA Repair and RNA Processing.
Borkar SA, Yin L, Venturi GM, Shen J, et al · · 2025 · cited 3× · PMID 39996757 · DOI 10.3390/cells14040285

Verify or expand the search:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Other University of North Carolina, Chapel Hill trials

Trials by the same sponsor.

NCT06841913 — Woodsmoke Exposure, Influenza Infection, and Nasal Immunity · Phase 4 · suspended
NCT07383428 — The INICIO-Guatemala Study · NA · not yet recruiting
NCT07528443 — Ultraprocessed Foods in Colombia · NA · not yet recruiting
NCT07507370 — CARED : A Novel Rapid Treatment Paradigm for Depression · NA · not yet recruiting
NCT07534254 — Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program · NA · 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 NCT00491556 (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 University of North Carolina, Chapel Hill
Last refreshed: 27 February 2017

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/NCT00491556.

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