HIV InfectionsPhase 2NCT00000880
A Study to Test the Effect of Cyclosporine on the Immune System of Patients With Early HIV Disease
A Phase 2 study testing Cyclosporine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of low doses of cyclosporine (CsA) in patients with early HIV infection and to evaluate its effect on the immune system. Activation of T cells (cells of the immune system) leads to HIV replication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cyclosporine
- How many people
- 30 participants
- Where
- 12 sitesUnited States
- Study dates
- Start not givento May 2000
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are HIV-positive.
- Have a CD4 count greater than or equal to 500/mm3.
- Have a plasma HIV RNA level greater than 600 copies/ml.
- Are over 18 years of age.
- Agree to practice abstinence or use barrier methods of birth control during the study.
Who cannot join
- You will not be eligible for this study if you:
- Have a history of an AIDS-defining illness, autoimmune disease, or hypertension.
- Have renal disease.
- Have any active infection other than HIV.
- Have used certain antiretroviral medications.
- Are pregnant.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Northwestern Univ Med School
Chicago, Illinois, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Case Western Reserve Univ
Cleveland, Ohio, 44106
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Univ of Texas Med Branch
Galveston, Texas, 77555
Beth Israel Med Ctr
New York, New York, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
San Francisco Gen Hosp
San Francisco, California, 941102859
Univ of Washington
Seattle, Washington, 98104
About this study
Official title: Phase II Study of Cyclosporin (Neoral) in Immune Activation and HIV Expression in Early HIV Disease
The purpose of this study is to determine the safety and effectiveness of low doses of cyclosporine (CsA) in patients with early HIV infection and to evaluate its effect on the immune system.
Activation of T cells (cells of the immune system) leads to HIV replication. Inhibition of immune activation is therefore a potentially important area of therapy for patients with early HIV infection. CsA is capable of decreasing T cell activation, which in turn may decrease HIV replication.
Read the detailed description
There is increasing data on the potential for inhibition of immune activation as primary therapy for HIV infection. The rationale of CsA therapy is to decrease T cell activation in patients with early HIV infection. Activation of T cells leads to translation and transcription of provirus, release of viral progeny, and ultimately cell death. T cell activation also leads to increased cell death via apoptosis. CsA is capable of inhibiting both these events and thus may lead to decreased CD4 cell turnover.
This study has 2 arms of 15 patients each. Patients in Arm I receive placebo. Patients in Arm II receive CsA. Each arm is further divided into 2 strata. Stratum 1 patients are not allowed to receive antiretroviral therapy. Stratum 2 patients must receive 1 of the following 4 stable nucleoside analogue combinations:
- Zidovudine (ZDV) plus lamivudine (3TC)
- ZDV plus didanosine (ddI)
- Stavudine (d4T) plus 3TC
- d4T plus ddI.
- Conditions
- HIV Infections
- Being tested
- Cyclosporine
- Keywords
- T-Lymphocytes, Lymphocyte Transformation, HIV-1, Drug Therapy, Combination, Immunosuppressive Agents, Apoptosis, Cyclosporine, Anti-HIV Agents
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclosporineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- L Calabrese, Study chairM Lederman, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000880
- Sponsor's protocol ID
- ACTG 334
- Other IDs
- 11306
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 28 Oct 2021
- Results posted
- No
Publications
Calabrese LH, Lederman MM, Spritzler J, Coombs RW, Fox L, Schock B, Yen-Lieberman B, Johnson R, Mildvan D, Parekh N; AIDS Clinical Trials Group 334 Investigators. Placebo-controlled trial of cyclosporin-A in HIV-1 disease: implications for solid organ transplantation. J Acquir Immune Defic Syndr. 2002 Apr 1;29(4):356-62. doi: 10.1097/00126334-200204010-00005.
PubMed 11917239
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Cyclosporin (Neoral) in Immune Activation and HIV Expression in Early HIV Disease
- ClinicalTrials.gov ID
- NCT00000880
- Acronym / sponsor ID
- ACTG 334
- Conditions
- HIV Infections
- Keywords
- T-Lymphocytes, Lymphocyte Transformation, HIV-1, Drug Therapy, Combination, Immunosuppressive Agents, Apoptosis, Cyclosporine, Anti-HIV Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 2000 (actual)
- First posted
- 31 Aug 2001 (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.
The purpose of this study is to determine the safety and effectiveness of low doses of cyclosporine (CsA) in patients with early HIV infection and to evaluate its effect on the immune system.
Activation of T cells (cells of the immune system) leads to HIV replication. Inhibition of immune activation is therefore a potentially important area of therapy for patients with early HIV infection. CsA is capable of decreasing T cell activation, which in turn may decrease HIV replication.
Detailed description
There is increasing data on the potential for inhibition of immune activation as primary therapy for HIV infection. The rationale of CsA therapy is to decrease T cell activation in patients with early HIV infection. Activation of T cells leads to translation and transcription of provirus, release of viral progeny, and ultimately cell death. T cell activation also leads to increased cell death via apoptosis. CsA is capable of inhibiting both these events and thus may lead to decreased CD4 cell turnover.
This study has 2 arms of 15 patients each. Patients in Arm I receive placebo. Patients in Arm II receive CsA. Each arm is further divided into 2 strata. Stratum 1 patients are not allowed to receive antiretroviral therapy. Stratum 2 patients must receive 1 of the following 4 stable nucleoside analogue combinations:
- Zidovudine (ZDV) plus lamivudine (3TC)
- ZDV plus didanosine (ddI)
- Stavudine (d4T) plus 3TC
- d4T plus ddI.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are HIV-positive.
- Have a CD4 count greater than or equal to 500/mm3.
- Have a plasma HIV RNA level greater than 600 copies/ml.
- Are over 18 years of age.
- Agree to practice abstinence or use barrier methods of birth control during the study.
Key exclusion criteria (6 listed)
- Have a history of an AIDS-defining illness, autoimmune disease, or hypertension.
- Have renal disease.
- Have any active infection other than HIV.
- Have used certain antiretroviral medications.
- Are pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine | Drug | – |
Primary outcome
Not reported in the source record.
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 28 Oct 2021.
- Background: PubMed 11917239Calabrese LH, Lederman MM, Spritzler J, Coombs RW, Fox L, Schock B, Yen-Lieberman B, Johnson R, Mildvan D, Parekh N; AIDS Clinical Trials Group 334 Investigators. Placebo-controlled trial of cyclosporin-A in HIV-1 disease: implications for solid organ transplantation. J Acquir Immune Defic Syndr. 2002 Apr 1;29(4):356-62. doi: 10.1097/00126334-200204010-00005.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
L Calabrese study chair
M Lederman study chair
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclosporine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites 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 6 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000880, which also lists 1 linked publication.
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 28 Oct 2021.