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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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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections HIV Wasting Syndrome |
Drug: Thalidomide |
Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
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 |
Estimated Enrollment: | 75 |
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.
![](https://webarchive.library.unt.edu/web/20130309095632im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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United States, California | |
Marin County Specialty Clinic | |
Greenbrae, California, United States, 94904 | |
AIDS Community Research Consortium | |
Redwood City, California, United States, 940631633 | |
UCSD Med Ctr - Owen Clinic | |
San Diego, California, United States, 921038681 | |
Kaiser Permanente Med Ctr | |
San Francisco, California, United States, 94115 | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 94110 | |
Gottlieb Med Group | |
Sherman Oaks, California, United States, 91403 | |
United States, District of Columbia | |
George Washington Univ Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Community Research Initiative of South Florida | |
Coral Gables, Florida, United States, 33146 | |
United States, Missouri | |
Kansas City AIDS Research Consortium | |
Kansas City, Missouri, United States, 64111 | |
United States, New Jersey | |
Saint Michael's Med Ctr | |
Newark, New Jersey, United States, 07102 | |
United States, New York | |
Rockefeller Univ | |
New York, New York, United States, 10021 | |
United States, Pennsylvania | |
Thomas Jefferson Med College | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Washington | |
Advanced Research Management | |
Seattle, Washington, United States, 981225314 |
![](https://webarchive.library.unt.edu/web/20130309095632im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
ClinicalTrials.gov Identifier: | NCT00002127 History of Changes |
Other Study ID Numbers: | 230A, W-001 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome Cachexia Thalidomide |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Wasting Syndrome Weight Loss HIV Wasting Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Metabolic Diseases |
Nutrition Disorders Body Weight Changes Body Weight Signs and Symptoms Thalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents |
ClinicalTrials.gov processed this record on March 07, 2013