Overview

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

Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Abacavir
Cyclosporine
Cyclosporins
Dideoxynucleosides
Lamivudine
Lopinavir
Ritonavir
Zidovudine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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