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CompletedNCT01048372Updated May 21, 2013

Observational Study of Blood Treated With Cytolin

An observational study in HIV Infections, sponsored by CytoDyn, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-21.

Sponsored by CytoDyn, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 65 Years
Sex
All
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Study summary

Primary Objective: To determine the mechanism of Cytolin's effect on HIV replication from blood drawn from HIV-positive and HIV-negative individuals after exposure to Cytolin.

Read the detailed description

The initial phase of this in vitro study regarding the potential mechanisms of action of Cytolin was completed in January 2011. Given the data set to date, a decision has been made to extend the study. The extension will allow the Company to further confirm and extend the initial findings regarding the potential mechanism of action of Cytolin.

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Conditions studied

  • HIV Infections

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Keywords

  • HIV
  • monoclonal antibody
  • immune therapy
  • pathogenesis
  • cytotoxic T lymphocyte
  • anti-CD4
  • anti-self
  • viral replication
  • Acute Infection
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In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 20 is below the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

CytoDyn, Inc. is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 12 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult human subjects willing and able to have blood drawn at Massachusetts General Hospital in Boston, MA at baseline, three months and six months. All healthy volunteers have been enrolled and enrollment is now open only to subjects with earlyh HIV infection.

Eligibility criteria

Early HIV Infection

Inclusion Criteria:

  • HIV seropositive
  • viral load \< 100,000 copies/ml
  • CD4+ > 350 cells/ul
  • Ability and willingness to give written informed consent.

Control Group

Inclusion Criteria:

  • HIV seronegative subjects identified as HIV uninfected by a nonreactive HIV 1/2 ELISA.
  • Ability and willingness to give written informed consent.

Exclusion Criteria:

  • Presentation with an opportunistic infection or AIDS-defining illness.
  • Receipt of investigational research agent within 30 days prior to study entry.
  • Prior receipt of experimental HIV vaccine, sham vector or adjuvant.
  • Receipt of immunosuppressive medications or immune modulators within the past six months. Individuals taking corticosteroid nasal spray for allergic rhinitis, topical steroid or over the counter medications for acute, uncomplicated dermatitis for a period no longer than 14 days will not be excluded.
  • Active drug or alcohol use, dependence or psychiatric illness that in the opinion of the study investigator would interfere with adherence to study protocol.
  • Serious illness requiring hospitalization.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)

Groups and cohorts

  • Early HIV infection

    HIV infected adults with early evidence of suppressed cell-mediated immunity but whose disease has not progressed far enough to indicate antiretroviral therapy.

  • Control

    Healthy adults without HIV infection.

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What researchers measure

Primary outcomes

  1. T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals.

    Time frame: Entry, 3 months, 6 months

Secondary outcomes

  1. In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals.

    Time frame: Entry, 3 months, 6 months

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Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
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References and documents

Publications

  • Zarling JM, Ledbetter JA, Sias J, Fultz P, Eichberg J, Gjerset G, Moran PA. HIV-infected humans, but not chimpanzees, have circulating cytotoxic T lymphocytes that lyse uninfected CD4+ cells. J Immunol. 1990 Apr 15;144(8):2992-8. PubMed 1969880 ↗
  • Morimoto C, Rudd CE, Letvin NL, Schlossman SF. A novel epitope of the LFA-1 antigen which can distinguish killer effector and suppressor cells in human CD8 cells. Nature. 1987 Dec 3-9;330(6147):479-82. doi: 10.1038/330479a0. PubMed 2446140 ↗
  • Cavallin F, Traldi A, Zambello R. Phenotypical and functional evaluation of CD8+/S6F1+ T lymphocytes in haemophiliac individuals with HIV-1 infection. Clin Exp Immunol. 1993 Jul;93(1):51-5. doi: 10.1111/j.1365-2249.1993.tb06496.x. PubMed 8324903 ↗
  • Tsubota H, Lord CI, Watkins DI, Morimoto C, Letvin NL. A cytotoxic T lymphocyte inhibits acquired immunodeficiency syndrome virus replication in peripheral blood lymphocytes. J Exp Med. 1989 Apr 1;169(4):1421-34. doi: 10.1084/jem.169.4.1421. PubMed 2784486 ↗
  • Allen AD, Hart DN, Hechinger MK, Slattery MJ, Chesson CV 2nd, Vidikan P. Leukocyte adhesion molecules as a cofactor in AIDS: basic science and pilot study. Med Hypotheses. 1995 Aug;45(2):164-8. doi: 10.1016/0306-9877(95)90065-9. PubMed 8531839 ↗
  • Allen AD, Hillis T, Vidikan P, Beer V. Pitfalls in the use of surrogate markers for human immunodeficiency virus disease: further evidence on pathogenesis. Med Hypotheses. 1996 Jul;47(1):27-30. doi: 10.1016/s0306-9877(96)90038-9. PubMed 8819112 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01048372
Lead sponsor
CytoDyn, Inc.
Responsible party
Sponsor
First posted
Jan 13, 2010
Start date
Jan 2010
Primary completion
Jan 2011
Completion
Dec 2012
Last update
May 21, 2013

Study contacts

Eric S Rosenberg, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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