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Study · Randomized controlled trial · n = 178 · 1996

10 results

Recombinant human growth hormone in patients with HIV-associated wasting. A randomized, placebo-controlled trial. Serostim Study Group.

Schambelan M, Mulligan K, Grunfeld C, Daar ES, LaMarca A, Kotler DP, Wang J, Bozzette SA, Breitmeyer JB

Annals of internal medicine1 Dec 1996Cited by 180 (Europe PMC)

PMID8967667 (opens in a new tab)DOI10.7326/0003-4819-125-11-199612010-00002 (opens in a new tab)PepBankPUB-08967667
Publisher pagePubMedAsk about this study
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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 study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with HIV-associated wasting, GH increased weight by 1.6 +/- 3.7 kg (P < 0.001), with a between-group difference at week 12 (P = 0.011).

    In plain wordsIn patients with HIV-associated wasting, GH increased weight more than placebo.

    Peptide
    HGH (somatotropin)
    Outcome
    IncreaseBody weight
    Study

    n = 178

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.1 mg/kg per day (average 6 mg/d) · 12 weeksAs given in this study (human).

    Measurements

    Change in body weight
    1.6 kg
    growth hormone group
    Change in body weight
    0.1 kg
    placebo group

    Source sentences

    Summary
    Treatment with growth hormone resulted in a sustained and statistically significant increase in weight (mean increase +/- SD, 1.6 +/- 3.7 kg [P < 0.001]) and lean body mass (3.0 +/- 3.0 kg [P < 0.001]), accompanied by a decrease in body fat (-1.7 +/- 1.7 kg [P < 0.001]).
    5 context sentences
    Summary · context
    In contrast, in patients receiving placebo, weight (increase, 0.1 +/- 3.1 kg), lean body mass (decrease, 0.1 +/- 2.0 kg), and body fat (decrease, 0.3 +/- 2.2 kg) did not change significantly from baseline.
    Summary · context
    Differences between groups at week 12 were statistically significant (P = 0.011 for body weight and P < 0.001 for lean body mass and body fat).
    Summary · context
    Randomized, double-blind, placebo-controlled, multicenter trial.
    Summary · context
    178 HIV-infected patients with documented unintentional weight loss of at least 10% or weight less than 90% of the lower limit of ideal body weight.
    Summary · context
    Patients were randomly assigned to receive either recombinant human growth hormone, 0.1 mg/kg of body weight per day (average dosage, 6 mg/d) (n = 90) or placebo (n = 88) for 12 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with HIV-associated wasting, GH increased lean body mass by 3.0 +/- 3.0 kg (P < 0.001), exceeding placebo (P < 0.001).

    In plain wordsIn patients with HIV-associated wasting, GH increased lean body mass more than placebo.

    Peptide
    HGH (somatotropin)
    Outcome
    IncreaseLean body mass
    Study

    n = 178

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.1 mg/kg per day (average 6 mg/d) · 12 weeksAs given in this study (human).

    Measurements

    Change in lean body mass
    3 kg
    growth hormone group
    Change in lean body mass
    −0.1 kg
    placebo group

    Source sentences

    Summary
    Treatment with growth hormone resulted in a sustained and statistically significant increase in weight (mean increase +/- SD, 1.6 +/- 3.7 kg [P < 0.001]) and lean body mass (3.0 +/- 3.0 kg [P < 0.001]), accompanied by a decrease in body fat (-1.7 +/- 1.7 kg [P < 0.001]).
    5 context sentences
    Summary · context
    In contrast, in patients receiving placebo, weight (increase, 0.1 +/- 3.1 kg), lean body mass (decrease, 0.1 +/- 2.0 kg), and body fat (decrease, 0.3 +/- 2.2 kg) did not change significantly from baseline.
    Summary · context
    Differences between groups at week 12 were statistically significant (P = 0.011 for body weight and P < 0.001 for lean body mass and body fat).
    Summary · context
    Randomized, double-blind, placebo-controlled, multicenter trial.
    Summary · context
    178 HIV-infected patients with documented unintentional weight loss of at least 10% or weight less than 90% of the lower limit of ideal body weight.
    Summary · context
    Patients were randomly assigned to receive either recombinant human growth hormone, 0.1 mg/kg of body weight per day (average dosage, 6 mg/d) (n = 90) or placebo (n = 88) for 12 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with HIV-associated wasting, GH decreased body fat (-1.7 +/- 1.7 kg, P < 0.001), more than placebo (P < 0.001).

    In plain wordsIn patients with HIV-associated wasting, GH reduced body fat more than placebo.

    Peptide
    HGH (somatotropin)
    Outcome
    DecreaseBody fat
    Study

    n = 178

    Comparator
    Placebo
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    0.1 mg/kg per day (average 6 mg/d) · 12 weeksAs given in this study (human).

    Measurements

    Change in body fat
    −1.7 kg
    growth hormone group
    Change in body fat
    −0.3 kg
    placebo group

    Source sentences

    Summary
    Treatment with growth hormone resulted in a sustained and statistically significant increase in weight (mean increase +/- SD, 1.6 +/- 3.7 kg [P < 0.001]) and lean body mass (3.0 +/- 3.0 kg [P < 0.001]), accompanied by a decrease in body fat (-1.7 +/- 1.7 kg [P < 0.001]).
    5 context sentences
    Summary · context
    In contrast, in patients receiving placebo, weight (increase, 0.1 +/- 3.1 kg), lean body mass (decrease, 0.1 +/- 2.0 kg), and body fat (decrease, 0.3 +/- 2.2 kg) did not change significantly from baseline.
    Summary · context
    Differences between groups at week 12 were statistically significant (P = 0.011 for body weight and P < 0.001 for lean body mass and body fat).
    Summary · context
    Randomized, double-blind, placebo-controlled, multicenter trial.
    Summary · context
    178 HIV-infected patients with documented unintentional weight loss of at least 10% or weight less than 90% of the lower limit of ideal body weight.
    Summary · context
    Patients were randomly assigned to receive either recombinant human growth hormone, 0.1 mg/kg of body weight per day (average dosage, 6 mg/d) (n = 90) or placebo (n = 88) for 12 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with HIV-associated wasting, treadmill work output increased by 99 +/- 293 with GH versus 20 +/- 233 kg.m/min with placebo (P = 0.039).

    In plain wordsIn patients with HIV-associated wasting, GH increased treadmill work output more than placebo.

    Peptide
    HGH (somatotropin)
    Outcome
    IncreaseTreadmill work output
    Study

    n = 178

    Comparator
    Placebo
    Outcome group
    Exercise and physical function · Whole body
    Studied dose
    0.1 mg/kg per day (average 6 mg/d) · 12 weeksAs given in this study (human).

    Measurements

    Change in treadmill work output
    99 kg.m/min
    growth hormone group
    Change in treadmill work output
    20 kg.m/min
    placebo group

    Source sentences

    Summary
    A greater increase in treadmill work output was noted in the group receiving growth hormone (increase, 99 +/- 293 kg. m/min) compared with the group receiving placebo (increase, 20 +/- 233 kg.m/min)(P = 0.039).
    3 context sentences
    Summary · context
    Randomized, double-blind, placebo-controlled, multicenter trial.
    Summary · context
    178 HIV-infected patients with documented unintentional weight loss of at least 10% or weight less than 90% of the lower limit of ideal body weight.
    Summary · context
    Patients were randomly assigned to receive either recombinant human growth hormone, 0.1 mg/kg of body weight per day (average dosage, 6 mg/d) (n = 90) or placebo (n = 88) for 12 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with HIV-associated wasting, health status scores did not differ between GH and placebo after treatment.

    In plain wordsIn patients with HIV-associated wasting, quality of life did not differ between GH and placebo.

    Peptide
    HGH (somatotropin)
    Outcome
    No significant changeQuality of life
    Study

    n = 178

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    0.1 mg/kg per day (average 6 mg/d) · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Health status (quality of life) scores did not differ between groups at baseline or after treatment.
    3 context sentences
    Summary · context
    Randomized, double-blind, placebo-controlled, multicenter trial.
    Summary · context
    178 HIV-infected patients with documented unintentional weight loss of at least 10% or weight less than 90% of the lower limit of ideal body weight.
    Summary · context
    Patients were randomly assigned to receive either recombinant human growth hormone, 0.1 mg/kg of body weight per day (average dosage, 6 mg/d) (n = 90) or placebo (n = 88) for 12 weeks.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In patients with HIV-associated wasting, days of disability were the same with GH and placebo.

    In plain wordsIn patients with HIV-associated wasting, days of disability were the same with GH and placebo.

    Peptide
    HGH (somatotropin)
    Outcome
    No significant changeDays of disability
    Study

    n = 178

    Comparator
    Placebo
    Outcome group
    Exercise and physical function · Whole body
    Studied dose
    0.1 mg/kg per day (average 6 mg/d) · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Days of disability and use of medical resources were the same for both groups.
    3 context sentences
    Summary · context
    Randomized, double-blind, placebo-controlled, multicenter trial.
    Summary · context
    178 HIV-infected patients with documented unintentional weight loss of at least 10% or weight less than 90% of the lower limit of ideal body weight.
    Summary · context
    Patients were randomly assigned to receive either recombinant human growth hormone, 0.1 mg/kg of body weight per day (average dosage, 6 mg/d) (n = 90) or placebo (n = 88) for 12 weeks.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In patients with HIV-associated wasting, medical resource use was the same with GH and placebo.

    In plain wordsIn patients with HIV-associated wasting, medical resource use was the same with GH and placebo.

    Peptide
    HGH (somatotropin)
    Outcome
    No significant changeMedical resource use
    Study

    n = 178

    Comparator
    Placebo
    Outcome group
    Healthcare costs and utilization · Whole body
    Studied dose
    0.1 mg/kg per day (average 6 mg/d) · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Days of disability and use of medical resources were the same for both groups.
    3 context sentences
    Summary · context
    Randomized, double-blind, placebo-controlled, multicenter trial.
    Summary · context
    178 HIV-infected patients with documented unintentional weight loss of at least 10% or weight less than 90% of the lower limit of ideal body weight.
    Summary · context
    Patients were randomly assigned to receive either recombinant human growth hormone, 0.1 mg/kg of body weight per day (average dosage, 6 mg/d) (n = 90) or placebo (n = 88) for 12 weeks.
  8. 08HumanRandomized controlled trialSafety outcome

    In patients with HIV-associated wasting, clinical events did not differ significantly between GH and placebo.

    In plain wordsIn patients with HIV-associated wasting, clinical events did not differ significantly between GH and placebo.

    Peptide
    HGH (somatotropin)
    Outcome
    No significant changeClinical events
    Study

    n = 178

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.1 mg/kg per day (average 6 mg/d) · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment was was well tolerated; no significant differences were seen between groups in clinical events, progression of AIDS, CD4+ or CD8+ cell counts, or viral burden.
    3 context sentences
    Summary · context
    Randomized, double-blind, placebo-controlled, multicenter trial.
    Summary · context
    178 HIV-infected patients with documented unintentional weight loss of at least 10% or weight less than 90% of the lower limit of ideal body weight.
    Summary · context
    Patients were randomly assigned to receive either recombinant human growth hormone, 0.1 mg/kg of body weight per day (average dosage, 6 mg/d) (n = 90) or placebo (n = 88) for 12 weeks.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In patients with HIV-associated wasting, AIDS progression did not differ significantly between GH and placebo.

    In plain wordsIn patients with HIV-associated wasting, AIDS progression did not differ significantly between GH and placebo.

    Peptide
    HGH (somatotropin)
    Outcome
    No significant changeAIDS progression
    Study

    n = 178

    Comparator
    Placebo
    Outcome group
    Infection and antimicrobial activity · Infection
    Studied dose
    0.1 mg/kg per day (average 6 mg/d) · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment was was well tolerated; no significant differences were seen between groups in clinical events, progression of AIDS, CD4+ or CD8+ cell counts, or viral burden.
    3 context sentences
    Summary · context
    Randomized, double-blind, placebo-controlled, multicenter trial.
    Summary · context
    178 HIV-infected patients with documented unintentional weight loss of at least 10% or weight less than 90% of the lower limit of ideal body weight.
    Summary · context
    Patients were randomly assigned to receive either recombinant human growth hormone, 0.1 mg/kg of body weight per day (average dosage, 6 mg/d) (n = 90) or placebo (n = 88) for 12 weeks.
  10. 10HumanRandomized controlled trialEfficacy outcome

    In patients with HIV-associated wasting, CD4+ counts, CD8+ counts and viral burden did not differ significantly between GH and placebo.

    In plain wordsIn patients with HIV-associated wasting, immune cell counts and viral burden did not differ significantly between GH and placebo.

    Peptide
    HGH (somatotropin)
    Outcome
    No significant changeCD4+ and CD8+ counts and viral burden
    Study

    n = 178

    Comparator
    Placebo
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    0.1 mg/kg per day (average 6 mg/d) · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Treatment was was well tolerated; no significant differences were seen between groups in clinical events, progression of AIDS, CD4+ or CD8+ cell counts, or viral burden.
    3 context sentences
    Summary · context
    Randomized, double-blind, placebo-controlled, multicenter trial.
    Summary · context
    178 HIV-infected patients with documented unintentional weight loss of at least 10% or weight less than 90% of the lower limit of ideal body weight.
    Summary · context
    Patients were randomly assigned to receive either recombinant human growth hormone, 0.1 mg/kg of body weight per day (average dosage, 6 mg/d) (n = 90) or placebo (n = 88) for 12 weeks.

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedNot applicableNCT00050921

Administration of Growth Hormone to Increase CD4+ Count in Patients Taking Anti-HIV Drugs

National Institute of Allergy and Infectious Diseases (NIAID)n = 60Completion Mar 2005

HIV Infections

Trial pageClinicalTrials.govUpdated 1 Nov 2021

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

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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