A Study of Thalidomide in HIV-Infected Patients Who Are Receiving HAART

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Thalidomide

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Lymphocyte Transformation, Immunity, Cellular, Drug Therapy, Combination, Adjuvants, Immunologic, Thalidomide, Immunologic Memory, Streptococcus pneumoniae, Tetanus Toxoid, Pneumococcal Vaccines

Eligibility Criteria

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

Inclusion Criteria Patients must have: Documented HIV infection. CD4+ cell count between 300 and 500 cells/mm3. HIV-1 RNA < 500 by the branched-chain DNA assay (bDNA assay, Chiron) within 21 days of study entry [AS PER AMENDMENT 11/25/98: Undetectable-plasma HIV titers (as defined by the FDA) by the branched-chain DNA test]. Established B cell lines [deleted AS PER AMENDMENT 11/25/98]. Response to at least one recall antigen in an in vitro assay of lymphocyte proliferative responses. Life expectancy > 6 months [deleted AS PER AMENDMENT 11/25/98]. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Active opportunistic infection or HIV-related malignancy [HIV-related malignancy deleted AS PER AMENDMENT 11/25/98]. Peripheral neuropathy of grade 2 or higher by Division of AIDS toxicity criteria. Concurrent Medication: Excluded: Other investigational HIV-drugs. Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline. Patients with the following prior conditions are excluded: History of serious hypersensitivity to tetanus toxoid or any of the vaccine components. Prior Medication: Excluded: Previous immunization with pneumococcal polysaccharide vaccine [or, AS PER AMENDMENT 11/25/98, keyhole limpet hemocyanin vaccine]. Tetanus toxoid booster within 5 years [deleted AS PER AMENDMENT 11/25/98]. Other investigational HIV-drugs within 6 weeks of enrollment. Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline within 6 weeks of enrollment. Risk Behavior: Excluded: Active drug or alcohol abuse. Required: Effective combination antiretroviral therapy including two nucleoside analog agents (ZDV, 3TC, ddI, ddC, or d4T) and nelfinavir or indinavir, for at least one month prior to study entry. [AS PER AMENDMENT 11/25/98: On stable, effective, highly-active antiretroviral therapy with combinations of any FDA-approved anti-HIV drugs for at least 3 months prior to entry.]

Sites / Locations

Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002392

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Rockefeller University

1. Study Identification

Unique Protocol Identification Number

NCT00002392

Brief Title

A Study of Thalidomide in HIV-Infected Patients Who Are Receiving HAART

Official Title

A Study to Investigate the Potential of Thalidomide Treatment to Enhance Immune Responses in HIV-Infected Individuals Who Are Receiving Highly Active Antiretroviral Therapy.

Study Type

Interventional

2. Study Status

Record Verification Date

April 1999

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Rockefeller University

4. Oversight

5. Study Description

Brief Summary

To ascertain the effect of thalidomide on immune responses to vaccination with polyvalent pneumococcal polysaccharide vaccine and tetanus toxoid in HIV-infected patients; particularly, on markers of immune activation and parameters of specific, anti-HIV cellular immunity.

Detailed Description

Patients receive oral thalidomide in a blinded, placebo-controlled study. [AS PER AMENDMENT 11/25/98: This is a double-blind, placebo-controlled trial in which thalidomide or placebo is administered for 21 days. After the first week of therapy, patients receive immunizations with keyhole limpet hemocyanin and polyvalent pneumococcal vaccine. Study therapy is stopped for 2 weeks after the immunizations. Following the immunizations, detailed evaluations of the immune responses to the vaccines are conducted over the next 8 weeks.]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Lymphocyte Transformation, Immunity, Cellular, Drug Therapy, Combination, Adjuvants, Immunologic, Thalidomide, Immunologic Memory, Streptococcus pneumoniae, Tetanus Toxoid, Pneumococcal Vaccines

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Enrollment

12 (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 Patients must have: Documented HIV infection. CD4+ cell count between 300 and 500 cells/mm3. HIV-1 RNA < 500 by the branched-chain DNA assay (bDNA assay, Chiron) within 21 days of study entry [AS PER AMENDMENT 11/25/98: Undetectable-plasma HIV titers (as defined by the FDA) by the branched-chain DNA test]. Established B cell lines [deleted AS PER AMENDMENT 11/25/98]. Response to at least one recall antigen in an in vitro assay of lymphocyte proliferative responses. Life expectancy > 6 months [deleted AS PER AMENDMENT 11/25/98]. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Active opportunistic infection or HIV-related malignancy [HIV-related malignancy deleted AS PER AMENDMENT 11/25/98]. Peripheral neuropathy of grade 2 or higher by Division of AIDS toxicity criteria. Concurrent Medication: Excluded: Other investigational HIV-drugs. Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline. Patients with the following prior conditions are excluded: History of serious hypersensitivity to tetanus toxoid or any of the vaccine components. Prior Medication: Excluded: Previous immunization with pneumococcal polysaccharide vaccine [or, AS PER AMENDMENT 11/25/98, keyhole limpet hemocyanin vaccine]. Tetanus toxoid booster within 5 years [deleted AS PER AMENDMENT 11/25/98]. Other investigational HIV-drugs within 6 weeks of enrollment. Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline within 6 weeks of enrollment. Risk Behavior: Excluded: Active drug or alcohol abuse. Required: Effective combination antiretroviral therapy including two nucleoside analog agents (ZDV, 3TC, ddI, ddC, or d4T) and nelfinavir or indinavir, for at least one month prior to study entry. [AS PER AMENDMENT 11/25/98: On stable, effective, highly-active antiretroviral therapy with combinations of any FDA-approved anti-HIV drugs for at least 3 months prior to entry.]

Facility Information:

Facility Name

Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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