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A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome

Primary Purpose

HIV Infections, HIV Wasting Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
Celgene Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, Cachexia, Thalidomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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. Exclusion Criteria 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. Patients with the following prior conditions are excluded: Any neoplasms other than non-medicated (i.e., not receiving systemic or intralesional chemotherapy) Kaposi's sarcoma within 1 month prior to study entry. Prior intolerance to thalidomide. Prior Medication: Excluded: ddC within 1 month prior to study entry. Acute systemic therapy for opportunistic infections within 6 weeks prior to study entry. Agents that are anabolic, catabolic, or immunomodulatory (including interferons, megestrol, dronabinol, oxandrolone, growth hormone, systemic corticosteroids, and pentoxifylline) within 30 days prior to study entry. Prior Treatment: Excluded: Radiotherapy within 6 weeks prior to study entry. Required ONLY IF patient is on antiretroviral therapy: Stable regimen of AZT or ddI for at least 1 month prior to study entry. Active drug abuse within 3 months prior to study entry.

Sites / Locations

  • Marin County Specialty Clinic
  • AIDS Community Research Consortium
  • UCSD Med Ctr - Owen Clinic
  • San Francisco Gen Hosp
  • Kaiser Permanente Med Ctr
  • Gottlieb Med Group
  • George Washington Univ Med Ctr
  • Community Research Initiative of South Florida
  • Kansas City AIDS Research Consortium
  • Saint Michael's Med Ctr
  • Rockefeller Univ
  • Thomas Jefferson Med College
  • Advanced Research Management

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00002127
Brief Title
A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
Official Title
A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Celgene Corporation

4. Oversight

5. Study Description

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.
Detailed Description
Patients are randomized to receive either thalidomide at 1 of 2 doses or placebo for 8 weeks. Patients who respond may continue in double-blinded treatment for an additional 4 weeks; nonresponding patients may receive thalidomide for up to 4 weeks. Per amendment, patients may receive thalidomide for more than 12 weeks on a compassionate basis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Wasting Syndrome
Keywords
Acquired Immunodeficiency Syndrome, Cachexia, Thalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thalidomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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. Patients with the following prior conditions are excluded: Any neoplasms other than non-medicated (i.e., not receiving systemic or intralesional chemotherapy) Kaposi's sarcoma within 1 month prior to study entry. Prior intolerance to thalidomide. Prior Medication: Excluded: ddC within 1 month prior to study entry. Acute systemic therapy for opportunistic infections within 6 weeks prior to study entry. Agents that are anabolic, catabolic, or immunomodulatory (including interferons, megestrol, dronabinol, oxandrolone, growth hormone, systemic corticosteroids, and pentoxifylline) within 30 days prior to study entry. Prior Treatment: Excluded: Radiotherapy within 6 weeks prior to study entry. Required ONLY IF patient is on antiretroviral therapy: Stable regimen of AZT or ddI for at least 1 month prior to study entry. Active drug abuse within 3 months prior to study entry.
Facility Information:
Facility Name
Marin County Specialty Clinic
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
940631633
Country
United States
Facility Name
UCSD Med Ctr - Owen Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
921038681
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Gottlieb Med Group
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Community Research Initiative of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Kansas City AIDS Research Consortium
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Saint Michael's Med Ctr
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Rockefeller Univ
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Thomas Jefferson Med College
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Advanced Research Management
City
Seattle
State/Province
Washington
ZIP/Postal Code
981225314
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9170807
Citation
Stirling D, Sherman M, Strauss S. Thalidomide. A surprising recovery. J Am Pharm Assoc (Wash). 1997 May-Jun;NS37(3):306-13.
Results Reference
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A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome

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