Safety and Tolerability of Z-100 in Patients With Early HIV Infection

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV positive but do not show symptoms.
• Are male or female, 18 years or older.
• Have not received treatment for HIV.
• Have received treatment but have discontinued HAART for at least 8 weeks prior to screening, have had stable viral loads on at least 2 separate time points at least 1 month apart including screening, and have had stable CD4 levels on at least 2 separate time points at least 1 month apart including screening.
• Use birth control while on the study and during the follow-up period.
• Have viral loads of 2,000 to 55,000 copies/ml within 2 weeks of randomization.
• Have CD4 counts of greater than 350 cells/mm within 2 weeks of randomization.
• Have a negative serum pregnancy test within 2 weeks of randomization (women able to have children).

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have failed HAART treatment.
• Have opportunistic infection or cancer.
• Have a history of tuberculosis.
• Have very abnormal laboratory test results.
• Have heart, liver, kidney or nervous system conditions.
• Have serious problems digesting and absorbing food or have serious long-term diarrhea within 4
• weeks of randomization.
• Have received radiation (localized is allowed) or chemotherapy within 30 days before randomization.
• Have seizure disorders that cannot be controlled.
• Have received any other drugs that affect the immune system or experimental drugs within 60 days before randomization.
• Have had any vaccination within 15 days before randomization.
• Have a mental condition which makes the patient unable to understand what the study is about and what it involves.
• Have a history of alcohol or drug abuse, unless the investigator feels that it will not interfere with participation in the protocol.
• Are pregnant or breast-feeding.
• Have a history of being very sensitive to the study drug or similar drugs.