NCT00084149

Brief Summary

Cyclosporine A (CsA) is a common long-term treatment used to inhibit the immune response in transplant patients who receive donor organs. CsA may also help people with HIV. The purpose of this study is to determine the safety of and immune response to CsA when given with abacavir sulfate (ABC), lamivudine (3TC), and zidovudine (AZT), (ABC/3TC/AZT) and lopinavir/ritonavir (LPV/r) to HIV infected adults in the early stages of infection. Study hypothesis: The combination of CsA and LPV/r given to acutely infected individuals will result in lower levels of proviral DNA and latent infectious virus at 48 weeks compared to acute infected individuals treated with LPV/r alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started Feb 2004

Typical duration for phase_2 hiv-infections

Geographic Reach
1 country

4 active sites

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

February 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2004

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
10.7 years until next milestone

Results Posted

Study results publicly available

September 13, 2018

Completed
Last Updated

November 4, 2021

Status Verified

August 1, 2018

Enrollment Period

3.9 years

First QC Date

June 7, 2004

Results QC Date

January 5, 2016

Last Update Submit

November 2, 2021

Conditions

HIV Infections

Keywords

Acute InfectionTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Levels of Proviral DNA in Peripheral Blood Mononuclear Cells (PBMC) (log10)

    At 48 weeks after the start of treatment

Secondary Outcomes (6)

  • Adverse Events Related to Study Medication

    Up to 48 weeks

  • Proviral DNA Levels (log10)

    At Week 24

  • Proviral DNA (log10)

    At Week 12

  • HIV-1 Viral Load Levels

    At Week 48

  • Number of Patients With Viral Load Less Than 50 Copies/ml

    Week 48

  • +1 more secondary outcomes

Study Arms (2)

Cyclosporin

EXPERIMENTAL

Cyclosporin arm (Arm A) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily, 3 capsules or 2 tablets of lopinavir/ritonavir (LPV/r) twice daily, and liquid cyclosporin A (CsA) (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r.

Drug: Abacavir sulfate, Lamivudine, and ZidovudineDrug: Lopinavir/Ritonavir

No Cyclosporin

EXPERIMENTAL

The No Cyclosporin arm (Arm B) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily and 3 capsules or 2 tablets of lopinavir/ritonavir (LPV/r) twice daily for all 48 weeks

Drug: Abacavir sulfate, Lamivudine, and ZidovudineDrug: Lopinavir/Ritonavir

Interventions

Abacavir sulfate, Lamivudine, and ZidovudineDRUG

antiretroviral therapy

Also known as: Trizivir
CyclosporinNo Cyclosporin
Lopinavir/RitonavirDRUG

antiretroviral therapy

Also known as: Kaletra
CyclosporinNo Cyclosporin

Eligibility Criteria

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

You may qualify if:

  • Acute HIV infection with HIV viral load of more than 50,000 copies/ml AND either negative ELISA OR Western blot with 5 bands or less within 4 weeks prior to study entry
  • Hepatitis B surface antigen negative within 12 weeks prior to study entry
  • Hepatitis C antibody negative within 12 weeks prior to study entry
  • Willing to use acceptable methods of contraception

You may not qualify if:

  • Prior antiretroviral therapy. A patient who has undergone Post Exposure Prophylaxis (PEP) taken at least 6 months prior to study entry is not excluded.
  • Allergy or hypersensitivity to any study medications or their components
  • Require certain medications, including those that may alter CsA levels or cause renal dysfunction. More information on this criterion can be found in the protocol.
  • Any medical or psychiatric condition, including alcohol or drug abuse, that may interfere with adherence to study requirements
  • Weight less than 88 lbs (40 kg)
  • Uncontrolled hypertension
  • History of pancreatitis
  • History of cancer. Participants with cancer in remission who have not had treatment for at least 3 years may be eligible for this study.
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Minnesota, ACTU

Minneapolis, Minnesota, 55455-0392, United States

Location

Beth Israel Med. Ctr., ACTU

New York, New York, 10003, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016-6481, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109-1998, United States

Location

Related Publications (3)

  • Ravot E, Lisziewicz J, Lori F. New uses for old drugs in HIV infection: the role of hydroxyurea, cyclosporin and thalidomide. Drugs. 1999 Dec;58(6):953-63. doi: 10.2165/00003495-199958060-00001.

    PMID: 10651384BACKGROUND

  • Rizzardi GP, Harari A, Capiluppi B, Tambussi G, Ellefsen K, Ciuffreda D, Champagne P, Bart PA, Chave JP, Lazzarin A, Pantaleo G. Treatment of primary HIV-1 infection with cyclosporin A coupled with highly active antiretroviral therapy. J Clin Invest. 2002 Mar;109(5):681-8. doi: 10.1172/JCI14522.

    PMID: 11877476BACKGROUND

  • Rizzardi GP, Lazzarin A, Pantaleo G. Potential role of immune modulation in the effective long-term control of HIV-1 infection. J Biol Regul Homeost Agents. 2002 Jan-Mar;16(1):83-90.

    PMID: 12003181BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

abacavirLamivudineZidovudineabacavir, lamivudine, and zidovudine drug combinationLopinavirlopinavir-ritonavir drug combination

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)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidinePyrimidinones

Results Point of Contact

Title
Dr. Florin Vaida
Organization
University of California, San Diego
fvaida@ucsd.edu
619 543-8045

Study Officials

  • Martin Markowitz, MD

    Aaron Diamond AIDS Research Center

    STUDY CHAIR

  • Susan Little, MD

    Department of Medicine, University of California at San Diego

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2004

First Posted

June 8, 2004

Study Start

February 1, 2004

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

November 4, 2021

Results First Posted

September 13, 2018

Record last verified: 2018-08

Locations

US(4)