NCT00053430

Brief Summary

Despite treatment with anti-HIV drugs, people infected with HIV continue to have problems with their immune systems. This study will evaluate whether the drug thalidomide, which stimulates the immune system's T cells, can improve immune system function in people with HIV.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

4.3 years

First QC Date

January 29, 2003

Last Update Submit

August 6, 2009

Conditions

HIV Infections

Keywords

Immune ModulationThalidomideImmune reconstitutionTreatment Experienced

Outcome Measures

Primary Outcomes (4)

  • Doubling in HIV Pol-specific CD8 cells, measured by ELISPOT

    Through Day 28

  • Increase in CMV pp65 CD8 cells, measured by ELISPOT in the thalidomide treatment group

    Throughout study

  • Increase in HIV p24-specific IFN-gamma-secreting CD4 cells in the thalidomide treatment group, measured by fluorescence-activated cell sorting (FACS)

    Throughout study

  • Increase in cytomegalovirus (CMV)-specific interferon (IFN)-gamma-secreting CD4 T cells in the thalidomide treatment group, measured by FACS

    Throughout study

Secondary Outcomes (2)

  • Increase in the frequency of keyhole limpet hemocyanin (KLH)-specific lymphocyte proliferative responses in the thalidomide treatment group

    Throughout study

  • Increase in adverse events in the thalidomide treatment group

    Throughout study

Study Arms (2)

1

EXPERIMENTAL

Participants will receive low dose thalidomide for 28 days

Drug: Thalidomide

2

PLACEBO COMPARATOR

Participants will receive low dose thalidomide placebo for 28 days

Drug: Thalidomide placebo

Interventions

ThalidomideDRUG

Tablet taken orally daily

1
Thalidomide placeboDRUG

Placebo tablet taken orally daily

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-infected for at least 5 years prior to study entry
  • CD4 count of 300/mm3 or above
  • Pre-HAART nadir CD4 count of 300/mm3 or less
  • CMV infection
  • HAART for 12 months prior to study entry
  • Same effective HAART regimen for 3 months prior to study entry
  • HIV viral load less than 200 copies/ml
  • Clinically stable

You may not qualify if:

  • Active opportunistic infection
  • Females of childbearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami School of Medicine

Miami, Florida, 33125, United States

Location

Related Publications (3)

  • Haslett PA, Hanekom WA, Muller G, Kaplan G. Thalidomide and a thalidomide analogue drug costimulate virus-specific CD8+ T cells in vitro. J Infect Dis. 2003 Mar 15;187(6):946-55. doi: 10.1086/368126. Epub 2003 Mar 6.

    PMID: 12660941BACKGROUND

  • Haslett PA, Klausner JD, Makonkawkeyoon S, Moreira A, Metatratip P, Boyle B, Kunachiwa W, Maneekarn N, Vongchan P, Corral LG, Elbeik T, Shen Z, Kaplan G. Thalidomide stimulates T cell responses and interleukin 12 production in HIV-infected patients. AIDS Res Hum Retroviruses. 1999 Sep 1;15(13):1169-79. doi: 10.1089/088922299310269.

    PMID: 10480630BACKGROUND

  • Matthews SJ, McCoy C. Thalidomide: a review of approved and investigational uses. Clin Ther. 2003 Feb;25(2):342-95. doi: 10.1016/s0149-2918(03)80085-1.

    PMID: 12749503BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Patrick Haslett, MD

    Department of Microbiology and Immunology, University of Miami School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 29, 2003

First Posted

January 30, 2003

Study Start

April 1, 2001

Primary Completion

August 1, 2005

Study Completion

February 1, 2006

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

US(1)