Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy
Official Title ^ICMJE	Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT/ddI or AZT/ddC) Anti-Retroviral Therapy
Brief Summary	To confirm results from a previous study in which the combination of thymopentin plus zidovudine ( AZT ), an antiretroviral agent, slowed disease progression in HIV-infected asymptomatic patients. To evaluate the efficacy and safety of thymopentin in HIV-infected asymptomatic patients receiving either monotherapy with AZT, didanosine ( ddI ), or stavudine ( d4T ), or combination antiretroviral therapy with AZT / ddI or AZT / zalcitabine ( ddC ).
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Thymopentin Drug: Stavudine Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria Patients must have: Asymptomatic HIV infection. CD4 count 100-400 cells/mm3. No HIV-associated neurologic abnormalities or constitutional symptoms. No oral hairy leukoplakia. At least 6 months of prior AZT. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Abnormal chest x-ray, consistent with active opportunistic infection. Hypersensitivity to thymopentin. Significant chronic underlying medical illness. Grade 2 or worse peripheral neuropathy. Concurrent Medication: Excluded: HIV vaccines. Investigational or non-FDA approved medication. Immunomodulatory therapies. Experimental therapies. Any antiretroviral therapy other than AZT, ddI, ddC, d4T, or 3TC. Patients with the following prior conditions are excluded: Herpes zoster (within the past year). Recurrent (> one episode) oral candidiasis (confirmed). Vulvovaginal candidiasis (persistent, frequent, or poorly responsive to therapy). Bacillary angiomatosis. Listeriosis. Idiopathic thrombocytopenia purpura. Prior Medication: Excluded at any time prior to study entry: More than one dose of thymopentin. Excluded within 30 days prior to study entry: HIV vaccines. Investigational or non-FDA approved medication. Immunomodulatory therapies. Experimental therapies. Any antiretroviral therapy other than AZT, ddI, ddC, d4T, or 3TC. Required: Prior AZT (>= 300 mg/day) for at least 6 months; on current regimen (any combination of approved nucleoside analogues) for at least 4 weeks. Significant active alcohol or drug abuse.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Puerto Rico

Administrative Information
NCT ID ^ICMJE	NCT00002109
Responsible Party
Study ID Numbers ^ICMJE	015H, 07.32.033-93
Study Sponsor ^ICMJE	Immunobiology Research Institute
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	March 1996
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP