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	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
3	NCT00647946 (ClinicalTrials.gov)	February 2003	27/3/2008	Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue	A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly Active Antiretroviral Therapy (HAART)	Lipodystrophy	Drug: tenofovir DF;Drug: abacavir 300mg twice daily	Gilead Sciences	NULL	Completed	18 Years	N/A	Both	100	Phase 2	United Kingdom
4	NCT00192660 (ClinicalTrials.gov)	February 2003	12/9/2005	HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)	Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Structure in HIV-infected Individuals, Naive to Therapy, Who Are Starting Therapy for the First Time	HIV-Associated Lipodystrophy Syndrome;Cardiovascular Disease	Drug: Lamivudine;Drug: Stavudine;Drug: Didanosine;Drug: Zidovudine;Drug: Tenofovir;Drug: Abacavir;Drug: Efavirenz (EFV);Drug: Nevirapine;Drug: Indinavir;Drug: Saquinavir;Drug: Amprenavir;Drug: Ritonavir;Drug: Nelfinavir;Drug: Tipranavir;Drug: enfuvirtide (T20)	Kirby Institute	St Vincent's Hospital, Sydney;National Heart, Lung, and Blood Institute (NHLBI)	Completed	18 Years	N/A	Both	80	Phase 4	Australia
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
6	NCT00021463 (ClinicalTrials.gov)	April 2001	14/7/2001	Changing to Nonprotease Inhibitor Treatment to Improve Side Effects	Phase II, Randomized, Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic Abnormalities	HIV Infections;Lipodystrophy	Drug: Abacavir sulfate , Lamivudine and Zidovudine;Drug: Abacavir sulfate;Drug: Efavirenz;Drug: Nevirapine	National Institute of Allergy and Infectious Diseases (NIAID)	NULL	Completed	13 Years	N/A	Both	342	Phase 2	United States
7	NCT00005764 (ClinicalTrials.gov)	May 2000	30/5/2000	A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients	Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)	HIV Infections;Lipodystrophy	Drug: Lamivudine /Zidovudine;Drug: Abacavir sulfate;Drug: Lamivudine	Glaxo Wellcome	NULL	Completed	18 Years	N/A	Both	100	Phase 4	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

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

NCT00647946
(ClinicalTrials.gov)

February 2003

27/3/2008

Study to Evaluate Changes in Limb Fat When Switching From a Thymidine Analogue

A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly Active Antiretroviral Therapy (HAART)

Lipodystrophy

Drug: tenofovir DF;Drug: abacavir 300mg twice daily

Gilead Sciences

NULL

Completed

18 Years

N/A

Both

100

Phase 2

United Kingdom

NCT00192660
(ClinicalTrials.gov)

February 2003

12/9/2005

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA001)

Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Structure in HIV-infected Individuals, Naive to Therapy, Who Are Starting Therapy for the First Time

HIV-Associated Lipodystrophy Syndrome;Cardiovascular Disease

Drug: Lamivudine;Drug: Stavudine;Drug: Didanosine;Drug: Zidovudine;Drug: Tenofovir;Drug: Abacavir;Drug: Efavirenz (EFV);Drug: Nevirapine;Drug: Indinavir;Drug: Saquinavir;Drug: Amprenavir;Drug: Ritonavir;Drug: Nelfinavir;Drug: Tipranavir;Drug: enfuvirtide (T20)

Kirby Institute

St Vincent's Hospital, Sydney;National Heart, Lung, and Blood Institute (NHLBI)

Completed

18 Years

N/A

Both

Phase 4

Australia

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

NCT00021463
(ClinicalTrials.gov)

April 2001

14/7/2001

Changing to Nonprotease Inhibitor Treatment to Improve Side Effects

Phase II, Randomized, Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic Abnormalities

HIV Infections;Lipodystrophy

Drug: Abacavir sulfate , Lamivudine and Zidovudine;Drug: Abacavir sulfate;Drug: Efavirenz;Drug: Nevirapine

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Completed

13 Years

N/A

Both

342

Phase 2

United States

NCT00005764
(ClinicalTrials.gov)

May 2000

30/5/2000

A Study of Increased Lactic Acid and Abnormal Fat Distribution in HIV-Positive Patients

Glaxo Wellcome Trial to Assess the Regression of Hyperlactatemia and to Evaluate the Regression of Established Lipodystrophy in HIV-1-Positive Subjects (TARHEEL)

HIV Infections;Lipodystrophy

Drug: Lamivudine /Zidovudine;Drug: Abacavir sulfate;Drug: Lamivudine

Glaxo Wellcome

NULL

Completed

18 Years

N/A

Both

100

Phase 4

United States