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

Original Study ID : 230A

Secondary ID : W-001

NCT ID : 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

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.

Source : NIH AIDS Clinical Trials Information Service

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.

Overall Status : Completed

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Double-Blind, Safety Study

Enrollment : 75

Verification Date : July 1997

First Received Date : November 2, 1999

Trial 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.

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : UCSD Med Ctr - Owen Clinic

City : San Diego

State : California

Zip Code : 921038681

Country : United States

Facility Name : Marin County Specialty Clinic

City : Greenbrae

State : California

Zip Code : 94904

Country : United States

Facility Name : Kaiser Permanente Med Ctr

City : San Francisco

State : California

Zip Code : 94115

Country : United States

Facility Name : Gottlieb Med Group

City : Sherman Oaks

State : California

Zip Code : 91403

Country : United States

Facility Name : AIDS Community Research Consortium

City : Redwood City

State : California

Zip Code : 940631633

Country : United States

Facility Name : San Francisco Gen Hosp

City : San Francisco

State : California

Zip Code : 94110

Country : United States

Facility Name : George Washington Univ Med Ctr

City : Washington

State : District of Columbia

Zip Code : 20037

Country : United States

Facility Name : Community Research Initiative of South Florida

City : Coral Gables

State : Florida

Zip Code : 33146

Country : United States

Facility Name : Kansas City AIDS Research Consortium

City : Kansas City

State : Missouri

Zip Code : 64111

Country : United States

Facility Name : Saint Michael's Med Ctr

City : Newark

State : New Jersey

Zip Code : 07102

Country : United States

Facility Name : Rockefeller Univ

City : New York

State : New York

Zip Code : 10021

Country : United States

Facility Name : Thomas Jefferson Med College

City : Philadelphia

State : Pennsylvania

Zip Code : 19107

Country : United States

Facility Name : Advanced Research Management

City : Seattle

State : Washington

Zip Code : 981225314

Country : United States

Refferances

PMID : 9170807

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

Interventions

Type : Drug

Name : Thalidomide

Clinical Trial Name - A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Tha