NCT00002127

Brief Summary

To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Geographic Reach
1 country

13 active sites

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, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsHIV Wasting Syndrome

Keywords

Acquired Immunodeficiency SyndromeCachexiaThalidomide

Interventions

ThalidomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Primary prophylaxis for opportunistic infections (if AFB blood culture negative).
  • Chronic suppressive therapy (maintenance) for opportunistic infections OTHER THAN Mycobacterium avium Complex (MAC).
  • Patients must have:
  • Documented HIV infection.
  • Wasting syndrome.
  • Negative blood PCR for acid-fast bacteria (AFB) or a negative AFB blood culture within 48 days prior to study entry.
  • No active opportunistic infection requiring systemic therapy within 6 weeks prior to study entry.
  • Life expectancy of at least 6 weeks.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Chronic diarrhea (five or more unformed stools per day).
  • Peripheral neuropathy of grade 2 or worse.
  • Requirement for tube feeding or intravenous feeding.
  • Any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure).
  • Inability to ingest at least a maintenance diet based on present weight.
  • Any condition that precludes study participation.
  • Not under the care of a primary physician.
  • Concurrent Medication:
  • Excluded:
  • Chronic suppressive therapy (maintenance) or secondary prophylaxis for Mycobacterium avium Complex (MAC) (suppressive therapy for other opportunistic infections is allowed).
  • Concurrent Treatment:
  • Excluded:
  • Radiotherapy.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Marin County Specialty Clinic

Greenbrae, California, 94904, United States

Location

AIDS Community Research Consortium

Redwood City, California, 940631633, United States

Location

UCSD Med Ctr - Owen Clinic

San Diego, California, 921038681, United States

Location

San Francisco Gen Hosp

San Francisco, California, 94110, United States

Location

Kaiser Permanente Med Ctr

San Francisco, California, 94115, United States

Location

Gottlieb Med Group

Sherman Oaks, California, 91403, United States

Location

George Washington Univ Med Ctr

Washington D.C., District of Columbia, 20037, United States

Location

Community Research Initiative of South Florida

Coral Gables, Florida, 33146, United States

Location

Kansas City AIDS Research Consortium

Kansas City, Missouri, 64111, United States

Location

Saint Michael's Med Ctr

Newark, New Jersey, 07102, United States

Location

Rockefeller Univ

New York, New York, 10021, United States

Location

Thomas Jefferson Med College

Philadelphia, Pennsylvania, 19107, United States

Location

Advanced Research Management

Seattle, Washington, 981225314, United States

Location

Related Publications (1)

  • Stirling D, Sherman M, Strauss S. Thalidomide. A surprising recovery. J Am Pharm Assoc (Wash). 1997 May-Jun;NS37(3):306-13.

    PMID: 9170807BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHIV Wasting SyndromeAcquired Immunodeficiency SyndromeCachexia

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesWasting SyndromeMetabolic DiseasesNutritional and Metabolic DiseasesNutrition DisordersSlow Virus DiseasesWeight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1997-07

Locations

US(13)