Clinical Trial of Brain-Penetrating HIV Drugs to Prevent Cognitive Impairment in China

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This primary aim of the project is to determine the association between antiretroviral therapy that better distributes into the central nervous system and prevention of HIV-associated neurocognitive impairment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborators: Beijing Ditan Hospital; Beijing YouAn Hospital; National Center for AIDS/STD Control and Prevention, China CDC; National Institute of Mental Health (NIMH); Peking University
• Treatments: Efavirenz; Lamivudine; Lamivudine, zidovudine drug combination; Nevirapine; Tenofovir; Zidovudine

Criteria

Inclusion Criteria:

• Men and women of at least 18 years of age.

• Ability and willingness of subject to give written informed consent.

• HIV-1 infection, as documented by enzyme-linked immunosorbent assay (ELISA) and confirmed by Western blot at any time prior to study entry. Plasma HIV-1 RNA is acceptable as an alternative confirmatory test.

• Antiretroviral drug-naïve, defined as ≤10 days of ART at any time prior to entry.

• Clinical HIV-1 RNA ≥1000 copies/mL obtained within 90 days of study screening.

• Clinical blood CD4+ cell count < 350/mm3 (for men) or <250/mm3 (for women) within 60 days of study screening.

• Performance within the expected normal range on the project's comprehensive, standardized battery of neuropsychological tests within 4 weeks.

• For women of child-bearing potential (WOCBP), negative serum or urine pregnancy test at screening and within 48 hours prior to initiating study medications.

Exclusion Criteria:

• Serious illness requiring systemic treatment or hospitalization within 4 weeks.

• Unacceptable laboratory values obtained within 4 weeks prior to study entry.

• Untreated syphilis.

• Child Pugh Class C hepatic impairment.

• Active Hepatitis B Virus infection.

• Known allergy/sensitivity to study drugs or their formulations.

• Severe or untreated conditions that could affect NP test performance.

• Such conditions include but are not limited to current substance use disorder, poorly controlled diabetes, uncontrolled seizure disorder, and any progressive CNS disorder (e.g., multiple sclerosis, CNS neoplasm) and evidence of acute intoxication or withdrawal, in the opinion of the study clinician.

• Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry.

• Currently breast-feeding.

• Requirement for any medications that have an absolute contraindication with any study drugs. In addition, we will exclude people taking rifampin.

• Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness.

• Prior use of nucleoside analogues, such as tenofovir, adefovir, or lamivudine, for treatment of hepatitis B for greater than 8 weeks while the subject was known to be HIV-infected.

• Any condition that, in the opinion of the investigators, would compromise the subject's ability to participate in the study.