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Study · Randomized controlled trial · 2008

8 results

Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation.

Falutz J, Allas S, Mamputu JC, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S

AIDS (London, England)1 Sept 2008Cited by 42 (Europe PMC)

PMID18690162 (opens in a new tab)DOI10.1097/qad.0b013e32830a5058 (opens in a new tab)PepBankPUB-18690162
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In HIV patients with central fat accumulation, tesamorelin was reported as generally well tolerated in the 26-week extension.

    In plain wordsIn HIV patients with belly fat gain, tesamorelin was reported as generally well tolerated over the extension.

    Peptide
    Tesamorelin
    Outcome
    No significant changeTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    2 mg · s.c. · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Tesamorelin was generally well tolerated.
    2 context sentences
    Summary · context
    HIV patients with central fat accumulation in the context of antiretroviral therapy were randomized to tesamorelin 2 mg (n = 273) or placebo (n = 137) s.c. daily for 26 weeks.
    Summary · context
    At week 26, patients originally on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 154) or placebo (T-P group, n = 50), whereas patients originally on placebo were switched to tesamorelin (P-T group, n = 111).
  2. 02HumanRandomized controlled trialSafety outcome

    In HIV patients with central fat accumulation, the prevalence of adverse events and serious adverse events in the extension phase was comparable with the initial phase.

    In plain wordsIn HIV patients with belly fat gain, side effects in the extension phase were about as common as in the first phase.

    Peptide
    Tesamorelin
    Outcome
    No significant changeAdverse events and serious adverse events in extension phase
    Study

    n: not reported in source

    Comparator
    Initial phase
    Outcome group
    Adverse events · Whole body
    Studied dose
    2 mg · s.c. · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    The prevalence of adverse events and serious adverse events during the extension phase was comparable with the initial phase.
    2 context sentences
    Summary · context
    HIV patients with central fat accumulation in the context of antiretroviral therapy were randomized to tesamorelin 2 mg (n = 273) or placebo (n = 137) s.c. daily for 26 weeks.
    Summary · context
    At week 26, patients originally on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 154) or placebo (T-P group, n = 50), whereas patients originally on placebo were switched to tesamorelin (P-T group, n = 111).
  3. 03HumanRandomized controlled trialSafety outcome

    In HIV patients with central fat accumulation, changes in glucose parameters over 52 weeks were not clinically significant and were similar to those after 26 weeks.

    In plain wordsIn HIV patients with belly fat gain, blood glucose changes over 52 weeks were not clinically important.

    Peptide
    Tesamorelin
    Outcome
    No significant changeGlucose parameters over 52 weeks
    Study

    n: not reported in source

    Comparator
    26-week values
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2 mg · s.c. · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Changes in glucose parameters over 52 weeks were not clinically significant and similar to those after 26 weeks.
    2 context sentences
    Summary · context
    HIV patients with central fat accumulation in the context of antiretroviral therapy were randomized to tesamorelin 2 mg (n = 273) or placebo (n = 137) s.c. daily for 26 weeks.
    Summary · context
    At week 26, patients originally on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 154) or placebo (T-P group, n = 50), whereas patients originally on placebo were switched to tesamorelin (P-T group, n = 111).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In HIV patients with central fat accumulation, the reduction in visceral adipose tissue (VAT) was sustained at -18% over 52 weeks of tesamorelin versus baseline.

    In plain wordsIn HIV patients with belly fat gain, the loss of belly organ fat of about 18% was sustained over 52 weeks of tesamorelin.

    Peptide
    Tesamorelin
    Outcome
    DecreaseVAT change over 52 weeks
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    2 mg · s.c. · 52 weeksAs given in this study (human).

    Measurements

    VAT change
    −18%
    52 weeks

    Source sentences

    Summary
    The change in VAT was sustained at -18% over 52 weeks of treatment (P < 0.001 versus baseline) as was the change in triglycerides (-51 mg/dl, P < 0.001 versus baseline).
    2 context sentences
    Summary · context
    HIV patients with central fat accumulation in the context of antiretroviral therapy were randomized to tesamorelin 2 mg (n = 273) or placebo (n = 137) s.c. daily for 26 weeks.
    Summary · context
    At week 26, patients originally on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 154) or placebo (T-P group, n = 50), whereas patients originally on placebo were switched to tesamorelin (P-T group, n = 111).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In HIV patients with central fat accumulation, the reduction in triglycerides was sustained over 52 weeks of tesamorelin versus baseline.

    In plain wordsIn HIV patients with belly fat gain, the lower triglycerides were sustained over 52 weeks of tesamorelin.

    Peptide
    Tesamorelin
    Outcome
    DecreaseTriglycerides change over 52 weeks
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    2 mg · s.c. · 52 weeksAs given in this study (human).

    Measurements

    Triglycerides change
    −51 mg/dl
    52 weeks

    Source sentences

    Summary
    The change in VAT was sustained at -18% over 52 weeks of treatment (P < 0.001 versus baseline) as was the change in triglycerides (-51 mg/dl, P < 0.001 versus baseline).
    2 context sentences
    Summary · context
    HIV patients with central fat accumulation in the context of antiretroviral therapy were randomized to tesamorelin 2 mg (n = 273) or placebo (n = 137) s.c. daily for 26 weeks.
    Summary · context
    At week 26, patients originally on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 154) or placebo (T-P group, n = 50), whereas patients originally on placebo were switched to tesamorelin (P-T group, n = 111).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In HIV patients with central fat accumulation, similar sustained beneficial effects were seen for total cholesterol over 52 weeks.

    In plain wordsIn HIV patients with belly fat gain, total cholesterol also showed a sustained benefit over 52 weeks.

    Peptide
    Tesamorelin
    Outcome
    DecreaseTotal cholesterol over 52 weeks
    Study

    n: not reported in source

    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    2 mg · s.c. · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Similar sustained beneficial effects were seen for total cholesterol, but high-density lipoprotein decreased minimally over 52 weeks.
    2 context sentences
    Summary · context
    HIV patients with central fat accumulation in the context of antiretroviral therapy were randomized to tesamorelin 2 mg (n = 273) or placebo (n = 137) s.c. daily for 26 weeks.
    Summary · context
    At week 26, patients originally on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 154) or placebo (T-P group, n = 50), whereas patients originally on placebo were switched to tesamorelin (P-T group, n = 111).
  7. 07HumanRandomized controlled trialEfficacy outcome

    In HIV patients with central fat accumulation, HDL cholesterol decreased minimally over 52 weeks.

    In plain wordsIn HIV patients with belly fat gain, HDL cholesterol fell slightly over 52 weeks.

    Peptide
    Tesamorelin
    Outcome
    DecreaseHDL cholesterol over 52 weeks
    Study

    n: not reported in source

    Outcome group
    Lipids · Metabolic and weight
    Studied dose
    2 mg · s.c. · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    but high-density lipoprotein decreased minimally over 52 weeks.
    2 context sentences
    Summary · context
    HIV patients with central fat accumulation in the context of antiretroviral therapy were randomized to tesamorelin 2 mg (n = 273) or placebo (n = 137) s.c. daily for 26 weeks.
    Summary · context
    At week 26, patients originally on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 154) or placebo (T-P group, n = 50), whereas patients originally on placebo were switched to tesamorelin (P-T group, n = 111).
  8. 08HumanRandomized controlled trialEfficacy outcome

    In HIV patients with central fat accumulation, VAT reaccumulated after tesamorelin was stopped.

    In plain wordsIn HIV patients with belly fat gain, belly organ fat came back after tesamorelin was stopped.

    Peptide
    Tesamorelin
    Outcome
    IncreaseVAT after tesamorelin discontinuation
    Study

    n: not reported in source

    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    2 mg · s.c. · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Upon discontinuation of tesamorelin, VAT reaccumulated.
    2 context sentences
    Summary · context
    HIV patients with central fat accumulation in the context of antiretroviral therapy were randomized to tesamorelin 2 mg (n = 273) or placebo (n = 137) s.c. daily for 26 weeks.
    Summary · context
    At week 26, patients originally on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 154) or placebo (T-P group, n = 50), whereas patients originally on placebo were switched to tesamorelin (P-T group, n = 111).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    9 Oct 2026, 19:08 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:13 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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