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	NCT00426296 (ClinicalTrials.gov)	August 2006	23/1/2007	SHARE: Simple HAART With Abacavir, Reyataz, and Epivir	An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of Abacavir 600 mg/Lamivudine 300 mg Once-Daily in Combination With Atazanavir 300 mg + Ritonavir 100 mg Once-Daily in Antiretroviral-Naïve HIV-1 Infected Subjects With Continuing Evaluation of Abacavir/Lamivudine Plus Atazanavir 400 mg for Maintenance Over an Additional 48 Weeks	HIV Infections;Lipodystrophy	Drug: atazanavir (Reyataz);Drug: ritonavir (Norvir)	Clinical Alliance for Research & Education - Infectious Diseases, LLC.	GlaxoSmithKline	Recruiting	18 Years	N/A	Both		Phase 4	United States
2	EUCTR2004-002740-10-DE (EUCTR)	07/11/2005	04/10/2005	A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised Protocol 03, version v8.0, incorporating Protocol Amendments 03, 04 and 05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY	A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised Protocol 03, version v8.0, incorporating Protocol Amendments 03, 04 and 05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY	HIV-infected individuals with lipodystrophy	Trade Name: Reyataz Product Name: Reyataz Product Code: BMS-232632 INN or Proposed INN: Atazanavir Other descriptive name: ATV Trade Name: Norvir Product Name: Norvir INN or Proposed INN: Ritonavir Other descriptive name: RTV	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	United Kingdom;Germany;Spain;Italy
3	EUCTR2004-002740-10-IT (EUCTR)	04/07/2005	24/01/2006	A phase IV, open-label, randomized, multicenter trial assessing a reyataz-based substitution approach in the management of lipodystrophy syndrome.	A phase IV, open-label, randomized, multicenter trial assessing a reyataz-based substitution approach in the management of lipodystrophy syndrome.	HIV MedDRA version: 6.1;Level: PT;Classification code 10049287	Trade Name: REYATAZ 150MG 60 CPS BL INN or Proposed INN: atazanavir	BRISTOL-M.SQUIBB	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Germany;United Kingdom;Spain;Italy
4	NCT00135356 (ClinicalTrials.gov)	July 2005	25/8/2005	Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome	A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing a Reyataz-Based Substitution Approach in the Management of Lipodystrophy Syndrome. Research Into Atazanavir in Lipodystrophy (The REAL Study)	HIV-Associated Lipodystrophy Syndrome	Drug: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs);Drug: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)	Bristol-Myers Squibb	NULL	Completed	18 Years	N/A	All	219	Phase 4	United States;Canada;France;Germany;Italy;Mexico;Poland;Spain;United Kingdom;Netherlands
5	EUCTR2004-002740-10-ES (EUCTR)	16/05/2005	17/05/2006	A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05. - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY	A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05. - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY	HIV-infected individuals with lipodystrophy	Trade Name: Reyataz Product Name: Reyataz Product Code: BMS-232632 INN or Proposed INN: Atazanavir Other descriptive name: ATV Trade Name: Norvir Product Name: Norvir INN or Proposed INN: Ritonavir Other descriptive name: RTV	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Germany;United Kingdom;Spain;Italy
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
6	EUCTR2004-002740-10-GB (EUCTR)	12/05/2005	19/04/2005	A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05, andRevised Protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY	A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05, andRevised Protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY	HIV-infected individuals with lipodystrophy	Trade Name: Reyataz Product Name: Reyataz Product Code: BMS-232632 INN or Proposed INN: Atazanavir Other descriptive name: ATV Trade Name: Norvir Product Name: Norvir INN or Proposed INN: Ritonavir Other descriptive name: RTV	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Spain;Germany;Italy;United Kingdom

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

NCT00426296
(ClinicalTrials.gov)

August 2006

23/1/2007

SHARE: Simple HAART With Abacavir, Reyataz, and Epivir

An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of Abacavir 600 mg/Lamivudine 300 mg Once-Daily in Combination With Atazanavir 300 mg + Ritonavir 100 mg Once-Daily in Antiretroviral-Naïve HIV-1 Infected Subjects With Continuing Evaluation of Abacavir/Lamivudine Plus Atazanavir 400 mg for Maintenance Over an Additional 48 Weeks

HIV Infections;Lipodystrophy

Drug: atazanavir (Reyataz);Drug: ritonavir (Norvir)

Clinical Alliance for Research & Education - Infectious Diseases, LLC.

GlaxoSmithKline

Recruiting

18 Years

N/A

Both

Phase 4

United States

EUCTR2004-002740-10-DE
(EUCTR)

07/11/2005

04/10/2005

A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised Protocol 03, version v8.0, incorporating Protocol Amendments 03, 04 and 05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY

HIV-infected individuals with lipodystrophy

Trade Name: Reyataz
Product Name: Reyataz
Product Code: BMS-232632
INN or Proposed INN: Atazanavir
Other descriptive name: ATV
Trade Name: Norvir
Product Name: Norvir
INN or Proposed INN: Ritonavir
Other descriptive name: RTV

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

United Kingdom;Germany;Spain;Italy

EUCTR2004-002740-10-IT
(EUCTR)

04/07/2005

24/01/2006

A phase IV, open-label, randomized, multicenter trial assessing a reyataz-based substitution approach in the management of lipodystrophy syndrome.

HIV
MedDRA version: 6.1;Level: PT;Classification code 10049287

Trade Name: REYATAZ 150MG 60 CPS BL
INN or Proposed INN: atazanavir

BRISTOL-M.SQUIBB

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Germany;United Kingdom;Spain;Italy

NCT00135356
(ClinicalTrials.gov)

July 2005

25/8/2005

Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing a Reyataz-Based Substitution Approach in the Management of Lipodystrophy Syndrome. Research Into Atazanavir in Lipodystrophy (The REAL Study)

HIV-Associated Lipodystrophy Syndrome

Drug: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs);Drug: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

219

Phase 4

United States;Canada;France;Germany;Italy;Mexico;Poland;Spain;United Kingdom;Netherlands

EUCTR2004-002740-10-ES
(EUCTR)

16/05/2005

17/05/2006

A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05Revised protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05. - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY

HIV-infected individuals with lipodystrophy

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Germany;United Kingdom;Spain;Italy

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

EUCTR2004-002740-10-GB
(EUCTR)

12/05/2005

19/04/2005

A PHASE IV, OPEN-LABEL, RANDOMIZED, MULTICENTER TRIAL ASSESSING A REYATAZ-BASED SUBSTITUTION APPROACH IN THE MANAGEMENT OF LIPODYSTROPHY SYNDROME. Pharmacogenetics Blood Sample Amendment 01, version 2.0 dated 13-Feb-05, andRevised Protocol 02 version 6.0, incorporating Amendment 03 and 04 dated 27-Oct-05 - THE REAL STUDY - RESEARCH INTO ATAZANAVIR IN LIPODYSTROPHY

HIV-infected individuals with lipodystrophy

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Spain;Germany;Italy;United Kingdom