DDrare: Database of Drug Development for Rare Diseases

ID	Disease name (Link within this page)	Number of trials
265	Lipodystrophy	2

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2005-004021-26-GB (EUCTR)	06/10/2005	05/09/2005	Longitudinal relationship between lipodystrophy and adipocyte mitochondria DNA in HIV Patients: comparison between Efavirenz (Sustiva) plus AZT/3TC (Combivir) and a less mitochrondial DNA-toxic regimen - Tenefovir/Emtricitabine (Truvada) plus Efavirenz. - Mitochondrial DNA Study	Longitudinal relationship between lipodystrophy and adipocyte mitochondria DNA in HIV Patients: comparison between Efavirenz (Sustiva) plus AZT/3TC (Combivir) and a less mitochrondial DNA-toxic regimen - Tenefovir/Emtricitabine (Truvada) plus Efavirenz. - Mitochondrial DNA Study	HIV		University Hospital Birmingham	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 4	United Kingdom
2	NCT00192621 (ClinicalTrials.gov)	November 2004	12/9/2005	Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects	A 3 Arm, Prospective Study to Compare the Effect of 6 Weeks Exposure to the Combination of Lopinavir (LPVr)/Combivir® (AZT/3TC) Versus Lopinavir Alone or Combivir® Alone in HIV-negative Healthy Subjects on the Development of Abnormalities of Lipid and Glucose Metabolism	HIV Infections;Dyslipidemias;Glucose Metabolism Disorders;Metabolic Diseases;Lipodystrophy;Cardiovascular Disease	Drug: Combivir (zidovudine [AZT] / lamivudine [3TC]);Drug: Kaletra (lopinavir [LPVr])	Kirby Institute	St Vincent's Hospital, Sydney;National Heart, Lung, and Blood Institute (NHLBI);Garvan Institute of Medical Research;Prince of Wales Hospital, Sydney	Completed	18 Years	N/A	Both	50	Phase 4	Australia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2005-004021-26-GB
(EUCTR)

06/10/2005

05/09/2005

Longitudinal relationship between lipodystrophy and adipocyte mitochondria DNA in HIV Patients: comparison between Efavirenz (Sustiva) plus AZT/3TC (Combivir) and a less mitochrondial DNA-toxic regimen - Tenefovir/Emtricitabine (Truvada) plus Efavirenz. - Mitochondrial DNA Study

HIV

University Hospital Birmingham

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

NCT00192621
(ClinicalTrials.gov)

November 2004

12/9/2005

Seronegatives and Metabolic Abnormalities Protocol 2 (SAMA002): Study to Compare the Effect of Kaletra and Combivir® in HIV-Negative Healthy Subjects

A 3 Arm, Prospective Study to Compare the Effect of 6 Weeks Exposure to the Combination of Lopinavir (LPVr)/Combivir® (AZT/3TC) Versus Lopinavir Alone or Combivir® Alone in HIV-negative Healthy Subjects on the Development of Abnormalities of Lipid and Glucose Metabolism

HIV Infections;Dyslipidemias;Glucose Metabolism Disorders;Metabolic Diseases;Lipodystrophy;Cardiovascular Disease

Drug: Combivir (zidovudine [AZT] / lamivudine [3TC]);Drug: Kaletra (lopinavir [LPVr])

Kirby Institute

St Vincent's Hospital, Sydney;National Heart, Lung, and Blood Institute (NHLBI);Garvan Institute of Medical Research;Prince of Wales Hospital, Sydney

Completed

18 Years

N/A

Both

Phase 4

Australia