Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Retinopathy HIV

Outcome Measures

Primary Outcomes (1)

Difference in percentages of subjects with a 3-step or greater progression (from both eyes) on the Early Treatment Diabetic Retinopathy Study (ETDRS) PERSON scale.
Subjects will undergo an opthamologic examination including fundus photographs at 3 month intervals for duration of 36 months
3 years

Secondary Outcomes (1)

Change from baseline in HbA1c by intensification of concomitant diabetic treatment
3 years

Study Arms (2)

EGRIFTA Treatment Grop

EXPERIMENTAL

Sterile, lyophilized, nonpyrogenic powder containing tesamorelin acetate with mannitol as excipient

Drug: Tesamorelin

Placebo

PLACEBO COMPARATOR

Placebo-controlled

Drug: Placebo-Control

Interventions

TesamorelinDrug

Daily 2 mg subcutaneous injections of tesamorelin

EGRIFTA Treatment Grop

Placebo-ControlDrug

3.0 mL vials

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subject has given written informed consent and is willing to comply with the requirements of the protocol;
Subject is an adult man or woman (≥ 18 years old);

Sponsors & Collaborators

Theratechnologies
Industrylead

Study Sites (24)

Southwest Center for HIV/AIDS

Phoenix, Arizona, 85004, United States

Spectrum Medical Group

Phoenix, Arizona, 85012, United States

5P21 Rand Schrader Clinic

Los Angeles, California, 90033, United States

University of California CARE Clinic, Los Angeles

Los Angeles, California, 90035, United States

Palmtree Clinical Research, Inc.

Palm Springs, California, 92262, United States

UCSD Antiviral Research Center

San Diego, California, 92103, United States

VAMC, Infectious Disease Section 111W

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

tesamorelin

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

Marilyn De Chantal

Enrollment

129 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 2, 2012

First Posted

May 4, 2012

Study Start

June 2012

Actual (reported)

Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

EGRIFTA Treatment Grop

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (24)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

EGRIFTA Treatment Grop

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (24)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations