Status:
COMPLETED
Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 i...
Detailed Description
During the early stages of HIV infection, HIV replicates unchecked, massive numbers of cluster of differentiation 4 (CD4) T cells are infected and destroyed, and other CD4 cells become infected but en...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00084149
Start Date
February 1 2004
End Date
January 1 2008
Last Update
November 4 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Minnesota, ACTU
Minneapolis, Minnesota, United States, 55455-0392
2
Beth Israel Med. Ctr., ACTU
New York, New York, United States, 10003
3
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016-6481
4
MetroHealth CRS
Cleveland, Ohio, United States, 44109-1998