Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00084149

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

54

Starts

2004-02-01

Expected to finish

2008-01-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• MetroHealth CRS — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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