NCT00352053 is a Phase 3 clinical trial of Tenofovir DF in HIV Infections, sponsored by Gilead Sciences.

Who is sponsoring NCT00352053?

NCT00352053 is sponsored by Gilead Sciences.

What drugs are being tested in NCT00352053?

Interventions in NCT00352053: Tenofovir DF, Placebo.

What condition does NCT00352053 study?

NCT00352053 studies HIV Infections.

Is NCT00352053 still recruiting?

NCT00352053 is currently completed. Last updated 15 June 2015.

Are results published for NCT00352053?

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

Last reviewed 2015-06-15 · How we verify

NCT00352053

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Tenofovir DF as Part of an Optimized Antiretroviral Regimen in HIV-1-Infected Adolescents

Completed Phase 3 Results posted Last updated 15 June 2015

What this trial tests

Phase 3 trial testing Tenofovir DF in HIV Infections in 87 participants. Completed in 1 December 2013.

Timeline

1 June 2006

Primary endpoint
1 September 2008

1 December 2013

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	87
Start date	1 June 2006
Primary completion	1 September 2008
Estimated completion	1 December 2013
Sites	18 locations across Brazil, Panama

Drugs / interventions tested

Tenofovir DF — full drug profile →
Placebo

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

Gilead Sciences — full company profile →

Who can join

Adults 12 to 17, 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.

Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA
Time frame: Baseline to 24 Weeks
DAVG24 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 24 minus the baseline value. DAVG24 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value. Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study dis

Sponsor's own description

The purpose of this study is to assess the safety and efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) plus a genotype-guided optimized background regimen (OBR) compared to placebo plus OBR in the treatment of human immunodeficiency virus type 1 (HIV-1) infected antiretroviral treatment-experienced adolescents with plasma HIV-1 ribonucleic acid (RNA) levels greater than or equal to 1000 copies/mL.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Tenofovir DF

Trials testing the same drug.

NCT02479880 — Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection · Phase 4 · terminated
NCT00528957 — Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children · Phase 3 · completed
NCT00078182 — Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia · Phase 2, PHASE3 · withdrawn

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 Gilead Sciences trials

Trials by the same sponsor.

NCT07115368 — Study of GS-1219 in Participants With HIV-1 · Phase 1 · terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain · completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated · Phase 2, PHASE3 · terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated

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 NCT00352053 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 15 June 2015

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/NCT00352053.

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