HIV InfectionsNCT01048372
Observational Study of Blood Treated With Cytolin
An observational study of HIV Infections, run by CytoDyn, Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- HIV seropositive
- viral load < 100,000 copies/ml
- CD4+ > 350 cells/ul
- Ability and willingness to give written informed consent.
- Control Group
- HIV seronegative subjects identified as HIV uninfected by a nonreactive HIV 1/2 ELISA.
- Ability and willingness to give written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: An Observational Study to Determine the In-vitro Immunologic and Virology Activity of Cytolin
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.
- Conditions
- HIV Infections
- Keywords
- HIV, monoclonal antibody, immune therapy, pathogenesis, cytotoxic T lymphocyte, anti-CD4, anti-self, viral replication, Acute Infection
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals.
Measured: Entry, 3 months, 6 months
Secondary outcomes (1)
In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals.
Measured: Entry, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytoDyn, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric S Rosenberg, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048372
- Sponsor's protocol ID
- 2009-P-0023471
- Status last verified
- May 2013
- First submitted
- 11 Jan 2010
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
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 1969880Morimoto 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 2446140Cavallin 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 8324903Tsubota 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 2784486Allen 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 8531839Allen 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
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Determine the In-vitro Immunologic and Virology Activity of Cytolin
- ClinicalTrials.gov ID
- NCT01048372
- Acronym / sponsor ID
- 2009-P-0023471
- Conditions
- HIV Infections
- Keywords
- HIV, monoclonal antibody, immune therapy, pathogenesis, cytotoxic T lymphocyte, anti-CD4, anti-self, viral replication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CytoDyn, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- HIV seropositive
- viral load < 100,000 copies/ml
- CD4+ > 350 cells/ul
- Ability and willingness to give written informed consent.
- Control Group
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals.
Time frame: Entry, 3 months, 6 months
1 secondary outcome
In-vitro suppression of viral replication following Cytolin treatment of blood harvested from HIV infected individuals.
Time frame: Entry, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
- Background: PubMed 1969880Zarling 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.
- Background: PubMed 2446140Morimoto 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.
- Background: PubMed 8324903Cavallin 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.
- Background: PubMed 2784486Tsubota 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.
- Background: PubMed 8531839Allen 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.
- Background: PubMed 8819112Allen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric S Rosenberg, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by CytoDyn, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T cell number and effector functions in Cytolin-treated blood harvested from HIV infected individuals. (time frame: Entry, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01048372, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.