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Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients

NCT ID: NCT02012556

Last Updated: 2013-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-07-31

Brief Summary

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The primary objective of the study is to determine the PK (tesamorelin) and PD (IGF-1) profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated administration once daily for 14 consecutive days. Secondary objectives include the evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous injections.

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tesamorelin

Group Type EXPERIMENTAL

Tesamorelin

Intervention Type DRUG

Interventions

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Tesamorelin

Intervention Type DRUG

Other Intervention Names

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Egrifta

Eligibility Criteria

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Inclusion Criteria

* Male or female, smoker or non-smoker, ≥18 and ≤65 years of age.
* HIV-positive with CD4 cell counts \>100 cells/mm3 and viral load \<10 000 copies/mL.
* On stable antiretroviral therapy (ART) regimen for at least 8 weeks prior to the first study drug administration.
* Body mass index (BMI) ≥ 20.0 kg/m2.

Exclusion Criteria

* Opportunistic infection or HIV-related disease within 3 months prior to study drug administration.
* History of malignancy of any organ or tissue (with the exception of basal cell carcinoma of the skin, in situ carcinoma of the cervix and stable Kaposi not having required treatment for the past 6 months).
* For male subjects, suspicion of prostate cancer.
* For female subjects, history of breast cancer or strong family history (first degree relative) of breast cancer.
* Known hypopituitarism, history of pituitary tumor/surgery, head irradiation or severe head trauma that had affected the somatotropic axis.
* Use of any experimental or marketed GH or GRF/GHRH products, GH secretagogues, IGF-1, or insulin-like growth factor binding protein-3 (IGFBP-3) within 6 months prior to study drug administration and throughout the study.
* Positive pregnancy test at screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Theratechnologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Larouche, MD

Role: PRINCIPAL_INVESTIGATOR

Anapharm

Locations

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Anapharm Montreal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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TH9507-CTR-1015

Identifier Type: -

Identifier Source: org_study_id