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Trial · Interventional

CompletedNot applicableRegistry data

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

NCTNCT00050921 (opens ClinicalTrials.gov in a new tab)Other idA5174Other idACTG A5198sOther id10092Other idACTG A5174

Overview

Status
Completed
Phase
Not applicable
Enrollment
60 participants
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · Nih
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Not stated
Primary completion
Not stated
Completion
Mar 2005
First posted
1 Jan 2003 (estimated)
Last update posted
1 Nov 2021
Conditions
HIV Infections

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is designed to evaluate the ability of growth hormone (GH, also known as somatropin) to increase CD4+ cell counts in patients taking anti-HIV drugs. The study is targeted toward patients with low levels of HIV who continue to have low CD4+ cell counts.

Interventions

  • somatropinDrug
  • Hepatitis A virus, inactivatedBiological
  • Keyhole-Limpet HemocyaninDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes0

Outcomes the sponsor listed as primary.

The registry lists no primary outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 1996

10 results

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

Schambelan et al. 1996Annals of internal medicinecited by 180

PMID 8967667DOI 10.7326/0003-4819-125-11-199612010-00002PUB-08967667

Full text at the publisher10 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria * HIV positive * Minimum of 1 year of treatment with HAART * CD4+ cell count \<350 cells/mm3 * HIV-1 RNA \<400 copies/ml for 6 months prior to study entry * Acceptable methods of contraception Exclusion Criteria * Serious medical illness requiring hospitalization within 14 days prior to study entry * Pregnant or breast-feeding * Taking certain medications * Allergy to r-hGH, hepatitis A vaccine, KLH, or their formulations, including allergies to shellfish * Active drug or alcohol dependence * Diabetes or uncontrolled hyperglycemia * Uncontrolled hypertension * History of carpal tunnel syndrome * Active neoplasm requiring treatment

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