Nutrition Intervention in AIDS Wasting

January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
There are no guidelines for appropriate nutritional management of weight loss or wasting in HIV infection. Some treatments may increase weight, but without improving muscle mass or quality of life. In this clinical trial AIDS patients with wasting are randomized to one of three nutritional strategies and studied over a 12-week period: 1) optimal oral nutrition with counseling and protein and calorie supplementation, and a placebo pill; 2) optimal oral nutrition with the oral androgen, oxandrolone at 20 mg daily; and 3) optimal oral nutrition with progressive resistance training (PRT). In all participants, dietary intervention is maximized by weekly personalized counseling to address individual issues and concerns. Two primary outcomes are assessed: thigh muscle mass and quality of life. Our findings can be used to develop guidelines for standards of nutritional care among AIDS patient with the wasting syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Loss of 10% of usual body weight, OR loss of 5% of usual body weight within the previous 6 months, OR BMI20kg/m2. If the candidate is taking a protease inhibitor, he/she must have not regained weight since initiating the medication over a period of at least 4 weeks prior to screening.
  • Documented HIV-positive
  • Able to eat
  • English-speaking
  • Compliance with medical regimens
  • For heterosexually active women: willingness to use an effective means of birth control
  • Patient and physician not planning to start new treatments for HIV infection or weight loss during the 12 weeks of study.

Exclusion Criteria:

  • Vomiting 1 time/day or diarrhea 4 times/day on average in the previous week
  • Fever 101 F within the previous week
  • Receiving induction treatment for one of the following (new diagnosis or recurrence within 4 weeks):

Pneumocystis carinii pneumonia Cryptococcal meningitis Cytomegalovirus retinitis or pneumonitis Toxoplasmosis Mycobacterium avium complex Visceral Kaposi's Sarcoma Lymphoma Pulmonary tuberculosis

  • Received corticosteroids, estrogens, progesterones, androgens, oral anticoagulants, or growth hormone within the previous three months
  • History of life-threatening reaction to oxandrolone or testosterone
  • Currently pregnant
  • History of congestive heart failure, myocardial infarction, angina/coronary artery disease, uncontrolled hypertension, cerebrovascular accident, hepatic failure, bleeding disorder, diabetes, nephrotic syndrome, cancer of the breast or prostate, or hypercalcemia
  • Milk product allergy
  • Current use of injected drugs
  • Participation in an exercise program or strength training within the previous 4 weeks
  • Any medical condition which renders the participant physically incapable of performing strength exercises
  • Serum total testosterone level at least 300ng/ml, unless patient and primary physician prepared to begin testosterone injections concurrent with study enrollment (men only).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sherwood Gorbach, MD, Tufts University
  • Study Director: Abby Shevitz, MD, Tufts University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 1998

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2000

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2000

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2000

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2000

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIAW (completed)
  • DK51011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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