DDrare: Database of Drug Development for Rare Diseases

Searched query = "Lipodystrophy", "Berardinelli-Seip syndrome", "Lawrence syndrome", "Barraquer-Simons syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 13 valent conjugated pneumococcal vaccine; 150 mg GSK1265744B; 300mg Gemcabene; 3TC; 600mg Gemcabene; ABC; ACETYL- L- CARNITINE; AKCEA-ANGPTL3-LRX; ATV; AZT; AZT/3TC; Abacavir; Abacavir 300mg twice daily; Abacavir sulfate; Abacavir sulfate, Lamivudine and Zidovudine; Acetate; Acetylcarnitine; Acipimox; Amprenavir; Antiretroviral/Anti HIV; Aramchol; Atazanavir; Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs); Atazanavir (Reyataz); Atazanavir/Ritonavir; Atorvastatin; Atorvastatin calcium; Avandia administration for 6-12 weeks; BMS-232632; Baricitinib; Behavioral: 60-minutes of steady state exercise; Behavioral: Diet; Behavioral: Exercise; Behavioral: Exercise Training; Behavioral: Exercise training; CD; CD-4 guided therapy interruption; COMBIVIR; Caffeine; Calcium; Carnitine; Cholic Acid; CoFactor; Cofactor supplementation (thiamine, riboflavin, L-carnitine); Combivir (zidovudine [AZT] / lamivudine [3TC]); Continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs); Cyclophosphamide; DIOSMIN; Device: Venus Versa; Device: poly-L-lactic acid; Didanosine; Different HAART regimens; Diosmin; Diosminex, 500 mg, tabletki powlekane; Dolutegravir; Dolutegravir 50 MG; Efavirenz; Efavirenz (EFV); Emtricitabine; Emtricitabine/tenofovir; Enfuvirtide; Enfuvirtide (T20); Fenofibrate; GSK1265744B (sodium salt) containing 14C-GSK1265744B; Gemcabene; Genetic: Amplification by PCR and direct sequencing on the entire coding sequence and intron-exons boundaries of the candidate gene; Genotropin (human recombinant Growth hormone); Glycerine; Growth Hormone Releasing Hormone; Growth hormone; High-carbohdyrate breakfast; High-dose REGN4461; Hu Leptin (A-100); Human growth hormone; Human recombinant leptin (metreleptin); ISIS 304801; Indinavir; Kaletra (lopinavir [LPVr]); L-Carnitine; L-Lactic acid; Lactic acid; Lamivudine; Lamivudine/Zidovudine; Leptin; Lopinavir; Lopinavir/Ritonavir; Lopinavir/ritonavir + nevirapine; Lopinavir/ritonavir + zidovudine + lamivudine; Low-Dose REGN4461; METRELEPTIN; Mecasermin; Metformin; Metformin hydrochloride; Metreleptin; Metrelpetin; Monotherapy (Lopinavir/ritonavir); Monotherapy (Lopinavir/ritonavir) + ABC/3TC; Myalept; Nelfinavir; Nelfinavir mesylate; Nevirapine; Niacin; Non-nucleoside reverse transcriptase inhibitors; Norvir; NucleomaxX; Nucleoside analogue sparing HAART regimen; Nucleoside reverse transcriptase inhibitors; Obeticholic Acid; Obeticholic acid; Other: Glycerine gel; Other: Observation; POLY-L-LACTIC ACID; Perform blood cells and fibroblasts biochemical and immuno-labeled investigations; Pioglitazone; Pioglitazone or metformin; Pneumococcal polysaccharide vaccine 23 valent; Pravastatin; Pravastatin sodium; Prevenar13; Procedure: testosterone injection; Protease inhibitor; Protease inhibitors; R-metHuLeptin; REYATAZ 150MG 60 CPS BL; RTV; Raltegravir; Recombinant human growth hormone; Recombinant human growth hormone + rosiglitazone; Reyataz; Riboflavin; Ritonavir; Ritonavir (Norvir); Rosiglitazone; Rosiglitazone maleate; ST200; SUSTIVA; Saquinavir; Serostim®[somatropin (rDNA origin) for injection]; Setmelanotide; Simvastatin; Somatropin; Standard continuous antiretroviral therapy; Stavudine; Sulfate; TAT4 Gel concentration A; TAT4 Gel concentration B; TH9507; TRUVADA; Tenofovir; Tenofovir DF; Tenofovir Disoproxil Fumarate; Tenofovir disoproxil; Tesamorelin; Tesamorelin (Egrifta); Testosterone; Thiamine; Tipranavir; Total Dietary Replacement; Use of lipid-lowering drugs.; VOLANESORSEN SODIUM, ApoC-III Antisense Oligonucleotide; Viral load driven treatment interruption; Volanesorsen; Zidovudine; [N-trans-3-Hexenoyl] Human Growth Hormone Releasing Factor (1-44) Acetate

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	NCT00865007 (ClinicalTrials.gov)	December 2008	18/3/2009	Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy	A Phase IV-III Comparative, Randomized, Open-label Study to Evaluate the Efficacy for the Recovery of Peripheral Fat (or of the Extremities) of Lopinavir/Ritonavir in Monotherapy Versus Abacavir/Lamivudine and Lopinavir/Ritonavir	HIV Infection;Lipodystrophy;HIV Infections	Drug: Monotherapy (Lopinavir/ritonavir);Drug: Monotherapy (Lopinavir/ritonavir) + ABC/3TC	Fundacion SEIMC-GESIDA	Abbott	Completed	18 Years	N/A	Both	88	Phase 4	Spain
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
3	NCT00139178 (ClinicalTrials.gov)	March 2004	30/8/2005	Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.	Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir. Influence on Metabolic Abnormalities	HIV Associated Lipodystrophy Syndrome.;HIV;Hypercholesterolemia;Lipoatrophy	Drug: Different HAART regimens	Danish HIV Research Group	Odense University Hospital;Rigshospitalet, Denmark;Hvidovre University Hospital;Aarhus University Hospital	Completed	18 Years	N/A	Both	100	Phase 4	Denmark
4	NCT00122226 (ClinicalTrials.gov)	January 2003	14/7/2005	MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)	MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)	HIV Infections;HIV-Associated Lipodystrophy Syndrome	Drug: Lopinavir /ritonavir + zidovudine + lamivudine;Drug: Lopinavir /ritonavir + nevirapine	VU University Medical Center	Abbott;Boehringer Ingelheim	Active, not recruiting	18 Years	70 Years	Male	50	Phase 4	Finland;Netherlands;Spain;United Kingdom
5	NCT00028314 (ClinicalTrials.gov)	March 2002	20/12/2001	Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients	A Restrictively Randomized, Open-Label, Controlled, Pilot Study of the Effect of a Thymidine Analogue Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral Fat Wasting	HIV Infections;Lipodystrophy;Wasting Disease	Drug: Abacavir sulfate;Drug: Atazanavir /Ritonavir;Drug: Lopinavir /Ritonavir;Drug: Nevirapine	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Completed	13 Years	N/A	Both	150	N/A	United States

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

NCT00865007
(ClinicalTrials.gov)

December 2008

18/3/2009

Lopinavir/r Monotherapy Versus Abacavir/Lamivudine and Lopinavir/r for Limb Fat Recovery in Persons With Lipoatrophy

A Phase IV-III Comparative, Randomized, Open-label Study to Evaluate the Efficacy for the Recovery of Peripheral Fat (or of the Extremities) of Lopinavir/Ritonavir in Monotherapy Versus Abacavir/Lamivudine and Lopinavir/Ritonavir

HIV Infection;Lipodystrophy;HIV Infections

Drug: Monotherapy (Lopinavir/ritonavir);Drug: Monotherapy (Lopinavir/ritonavir) + ABC/3TC

Fundacion SEIMC-GESIDA

Abbott

Completed

18 Years

N/A

Both

Phase 4

Spain

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

NCT00139178
(ClinicalTrials.gov)

March 2004

30/8/2005

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

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

HIV Associated Lipodystrophy Syndrome.;HIV;Hypercholesterolemia;Lipoatrophy

Drug: Different HAART regimens

Danish HIV Research Group

Odense University Hospital;Rigshospitalet, Denmark;Hvidovre University Hospital;Aarhus University Hospital

Completed

18 Years

N/A

Both

100

Phase 4

Denmark

NCT00122226
(ClinicalTrials.gov)

January 2003

14/7/2005

MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

HIV Infections;HIV-Associated Lipodystrophy Syndrome

Drug: Lopinavir /ritonavir + zidovudine + lamivudine;Drug: Lopinavir /ritonavir + nevirapine

VU University Medical Center

Abbott;Boehringer Ingelheim

Active, not recruiting

18 Years

70 Years

Male

Phase 4

Finland;Netherlands;Spain;United Kingdom

NCT00028314
(ClinicalTrials.gov)

March 2002

20/12/2001

Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients

A Restrictively Randomized, Open-Label, Controlled, Pilot Study of the Effect of a Thymidine Analogue Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral Fat Wasting

HIV Infections;Lipodystrophy;Wasting Disease

Drug: Abacavir sulfate;Drug: Atazanavir /Ritonavir;Drug: Lopinavir /Ritonavir;Drug: Nevirapine

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Completed

13 Years

N/A

Both

150

N/A

United States