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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002127
• Other study ID #: 230A
• Secondary ID: W-001
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 1997
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cachexia
• HIV Infections
• HIV Wasting Syndrome
• Syndrome

Intervention

Drug:
• Thalidomide

Locations

Country	Name	City	State
United States	Community Research Initiative of South Florida	Coral Gables	Florida
United States	Marin County Specialty Clinic	Greenbrae	California
United States	Kansas City AIDS Research Consortium	Kansas City	Missouri
United States	Rockefeller Univ	New York	New York
United States	Saint Michael's Med Ctr	Newark	New Jersey
United States	Thomas Jefferson Med College	Philadelphia	Pennsylvania
United States	AIDS Community Research Consortium	Redwood City	California
United States	UCSD Med Ctr - Owen Clinic	San Diego	California
United States	Kaiser Permanente Med Ctr	San Francisco	California
United States	San Francisco Gen Hosp	San Francisco	California
United States	Advanced Research Management	Seattle	Washington
United States	Gottlieb Med Group	Sherman Oaks	California
United States	George Washington Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Celgene Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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