Who is sponsoring NCT00139178?

NCT00139178 is sponsored by Danish HIV Research Group.

What drugs are being tested in NCT00139178?

Interventions in NCT00139178: Different HAART regimens.

What condition does NCT00139178 study?

NCT00139178 studies HIV Associated Lipodystrophy Syndrome., HIV, Hypercholesterolemia, Lipoatrophy.

Is NCT00139178 still recruiting?

NCT00139178 is currently completed. Last updated 2 September 2005.

Last reviewed 2005-09-02 · How we verify

NCT00139178

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

Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities

Completed Phase 4 Last updated 2 September 2005

What this trial tests

Phase 4 trial testing Different HAART regimens in HIV Associated Lipodystrophy Syndrome. in 100 participants. Completed in 1 April 2007.

Timeline

1 March 2004

1 April 2007

Quick facts

Lead sponsor	Danish HIV Research Group
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 March 2004
Estimated completion	1 April 2007
Sites	4 locations across Denmark

Drugs / interventions tested

Different HAART regimens — full drug profile →

Conditions studied

HIV Associated Lipodystrophy Syndrome. — all drugs for HIV Associated Lipodystrophy Syndrome. →
HIV — all drugs for HIV →
Hypercholesterolemia — all drugs for Hypercholesterolemia →
Lipoatrophy — all drugs for Lipoatrophy →

Sponsor

Danish HIV Research Group

Who can join

18 and older, any sex, with HIV Associated Lipodystrophy Syndrome. or HIV.

What's being measured

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

Changes in peripheral fat mass, determined by DEXA-Changes Change from baseline in fasting lipids and subsets hereof. Development of impaired glucose tolerance and insulin resistance.

Sponsor's own description

Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy. The main hypothesis of the study is that switching from thymidine-analogue based HAART will reverse lipoatrophy. We plan to perform an observational study recruiting up to 100 HIV-infected patients receiving Trizivir (zidovudine/lamivudine/abacavir). The patients will be offered an NRTI or lopinavir/ritonavir instead of zidovudine or they can choose to continue with Trizivir. The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning.

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:

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 NCT00139178 (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 Danish HIV Research Group
Last refreshed: 2 September 2005

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/NCT00139178.

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