← Human Trials & Peer-Reviewed Studies
Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
Plain-language guide to NCT02012556: phase 1 interventional trial of Tesamorelin, 18 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02012556
- Phase
- phase 1
- Status
- completed
- Start
- 2008-05
- Completion (planned or actual)
- 2008-07
- Participants
- 18 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- HIV
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Tesamorelin.
Secondary objectives include the evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous injections.
It had 1 arm (groups): Tesamorelin (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 18 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: opportunistic infection or hiv-related disease within 3 months prior to study drug administration; for male subjects, suspicion of prostate cancer; for female subjects, history of breast cancer or strong family history (first degree relative) of breast cancer.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Tesamorelin study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2008-05 with completion listed for 2008-07.
It ran at 1 site in Canada.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Area under the Plasma Concentration versus Time Curve (AUC) of Tesamorelin. Peak Plasma Concentration (Cmax) of Tesamorelin. Time to Maximum Plasma Concentration (Tmax) of Tesamorelin.
It also tracked 1 secondary outcome, for example Number of Subjects with Adverse Events as a Measure of Safety and Tolerability.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Tesamorelin in 18 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Tesamorelin compound page, all human trials.
Our Notes on the Compound
Tesamorelin: GH pulse → liver IGF-1 → mTOR and PI3K-AKT (muscle).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.