NCT00338767 is a Phase 2 clinical trial of Directly Observed Therapy (DOT) in HIV Infections, sponsored by Massachusetts General Hospital.

Who is sponsoring NCT00338767?

NCT00338767 is sponsored by Massachusetts General Hospital.

What drugs are being tested in NCT00338767?

Interventions in NCT00338767: Directly Observed Therapy (DOT), Fluoxetine.

What condition does NCT00338767 study?

NCT00338767 studies HIV Infections, Depression.

Is NCT00338767 still recruiting?

NCT00338767 is currently completed. Last updated 13 November 2013.

Last reviewed 2013-11-13 · How we verify

NCT00338767

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

Depression Treatment to Improve Antiretroviral Adherence

Completed Phase 2 Last updated 13 November 2013

What this trial tests

Phase 2 trial testing Directly Observed Therapy (DOT) in HIV Infections in 150 participants. Completed in 1 August 2006.

Timeline

1 January 2001

Primary endpoint
1 August 2006

1 August 2006

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	1 January 2001
Primary completion	1 August 2006
Estimated completion	1 August 2006
Sites	1 location across United States

Drugs / interventions tested

Directly Observed Therapy (DOT) — full drug profile →
Fluoxetine (fluoxetine) — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →
Depression — all drugs for Depression →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with HIV Infections or Depression. 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.

Improved depression scores
Time frame: Measured at the end of 9 months

Sponsor's own description

This study will evaluate the effectiveness of directly observed therapy plus antidepressant medication in improving adherence to antiretroviral drug therapy among HIV-infected homeless and marginally housed people with depression.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Does substance use compromise depression treatment in persons with HIV? Findings from a randomized controlled trial.
Grelotti DJ, Hammer GP, Dilley JW, Karasic DH, et al · · 2017 · cited 9× · PMID 27590273 · DOI 10.1080/09540121.2016.1226479

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 Massachusetts General Hospital trials

Trials by the same sponsor.

NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet 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 NCT00338767 (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 Massachusetts General Hospital
Last refreshed: 13 November 2013

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/NCT00338767.

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