Phase 2
N=54
Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00084149 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Levels of Proviral DNA in Peripheral Blood Mononuclear Cells (PBMC) (log10) — 1.88; 1.92 log10(copies/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Abacavir sulfate, Lamivudine, and Zidovudine (Drug); Lopinavir/Ritonavir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Levels of Proviral DNA in Peripheral Blood Mononuclear Cells (PBMC) (log10) |
1.88; 1.92 | — |
| SECONDARY Adverse Events Related to Study Medication |
1; 0 | — |
| SECONDARY Proviral DNA Levels (log10) |
2.12; 1.96 | — |
| SECONDARY Proviral DNA (log10) |
2.22; 2.13 | — |
| SECONDARY HIV-1 Viral Load Levels |
1.70; 1.70 | — |
| SECONDARY Number of Patients With Viral Load Less Than 50 Copies/ml |
27; 13 | — |
| SECONDARY CD4 T Cell Levels |
301; 287 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00084149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.