NCT00002182

Brief Summary

The purpose of this study is to see if megestrol acetate is safe and effective in treating HIV-infected children with failure to thrive (FTT).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 1998

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

PlacebosAppetite StimulantsMegestrol AcetateFailure to Thrive

Interventions

Megestrol acetateDRUG

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients must have:
  • Documented HIV infection.
  • Failure to thrive as defined by:
  • crossing 2 percentile lines on standard weight for age curves over time or less than 5% percentile weight for age and falling from the curve or loss of 10% of baseline body weight.
  • Resistant to oral nutritional supplementation (i.e., FTT despite a minimum 1-month trial of high-calorie oral supplements).
  • Free of significant acute illness (mild upper respiratory tract infections allowed).
  • Patients with chronic diarrhea allowed provided malabsorption and gastrointestinal infection ruled out.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms are excluded:
  • Gastrointestinal infection or malabsorption.
  • Significant acute illness.
  • Any identified, untreated cause for failure to thrive other than underlying HIV infection.
  • Medical contraindications to megestrol acetate.
  • Patients with any of the following prior conditions or symptoms are excluded:
  • Medical contraindications to megestrol acetate including a history of poorly-controlled hypertension, deep venous thrombosis, or heart failure.
  • History of prior megestrol acetate therapy in the past six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ of Puerto Rico / Med Science Campus

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Conditions

HIV InfectionsFailure to Thrive

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1998-07

Locations

PR(1)