NCT00324649 (RECOMB) is a Phase 4 clinical trial of Truvada in HIV-1, sponsored by Gilead Sciences.

Who is sponsoring NCT00324649?

NCT00324649 is sponsored by Gilead Sciences.

What drugs are being tested in NCT00324649?

Interventions in NCT00324649: Truvada, Zidovudine/lamivudine.

Is NCT00324649 still recruiting?

NCT00324649 is currently completed. Last updated 13 August 2015.

Are results published for NCT00324649?

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

Last reviewed 2015-08-13 · How we verify

NCT00324649: RECOMB

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

Pilot Phase IV, Multicenter, Randomized, Open-label and Controlled Study to Assess the Evolution of Peripheral Body Fat Distribution After Switching From Zidovudine Containing Backbone to Truvada in HIV-1-infected Patients on HAART (RECOMB Study).

Completed Phase 4 Results posted Last updated 13 August 2015

What this trial tests

Phase 4 trial testing Truvada in HIV-1 in 80 participants. Completed in 1 September 2008.

Timeline

1 May 2006

Primary endpoint
1 March 2008

1 September 2008

Quick facts

Lead sponsor	Gilead Sciences
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	1 May 2006
Primary completion	1 March 2008
Estimated completion	1 September 2008
Sites	1 location across Spain

Drugs / interventions tested

Truvada — full drug profile →
Zidovudine/lamivudine — full drug profile →

Conditions studied

HIV-1 — all drugs for HIV-1 →

Sponsor

Gilead Sciences — full company profile →

Who can join

18 and older, any sex, with HIV-1. 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.

Change From Baseline in Limb Fat at Week 48
Time frame: Baseline to Week 48
Limb fat was measured by DEXA. Change = Week 48 value minus baseline value.

Sponsor's own description

This study evaluated changes in body fat distribution in human immunodeficiency virus type 1 (HIV-1) infected participants who either switched from a zidovudine- plus lamivudine- containing highly active antiretroviral therapy (HAART) regimen to a regimen containing Truvada® (a fixed-dose combination tablet of emtricitabine \[FTC, 200 mg\] and tenofovir disoproxil fumarate \[TDF, 300 mg\]) or who remained on a zidovudine- plus lamivudine-containing regimen. Subjects continued their protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI).

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 Truvada

Trials testing the same drug.

NCT06631365 — PrEPsmart 2-1-1 Pilot · Phase 2 · recruiting
NCT06030557 — PrEPared-RN, CAN Nurse-Led Management of High-risk Patients for Pre-Exposure Prophylaxis (PrEP) · unknown
NCT05108935 — Providing PrEP, Hepatitis C Treatment, and MOUD Through Telemedicine at Greensboro SSP · NA · completed
NCT03512418 — Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps) · Phase 3 · completed
NCT03842436 — Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use · Phase 4 · completed

Other recruiting trials for HIV-1

Currently open trials in the same condition.

NCT06517693 — Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1 · Phase 1 · recruiting
NCT06252402 — CMV-specific HIV-CAR T Cells as Immunotherapy for HIV/AIDS · EARLY_PHASE1 · recruiting
NCT05612178 — A Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs · Phase 1 · active not recruiting
NCT00980538 — TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants · Phase 3 · active not 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 NCT00324649 (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: 13 August 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/NCT00324649.

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