At a glance
ClinicalIndex Comparison Record- ✓Acute HIV infection with HIV viral load >50,000 copies/ml
- ✓Negative ELISA or Western blot with ≤5 bands 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
- ✕Prior antiretroviral therapy (except PEP taken ≥6 months prior to study entry)
- ✕Allergy or hypersensitivity to any study medications or their components
- ✕Medications that may alter cyclosporine A levels or cause renal dysfunction
- ✕Medical or psychiatric condition, including alcohol or drug abuse, that may interfere with adherence
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Study of the Safety, Immunologic, and Virologic Effects of Cyclosporine A in Conjunction With Trizivir(R) and Kaletra(R) Versus Trizivir(R) and Kaletra(R) Alone During Primary HIV-1 Infection
In Brief
A Phase 2 clinical trial evaluating Abacavir sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir for HIV Infections. Completed, enrolled 54 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
antiretroviral therapy
antiretroviral therapy