A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males

NCT00040300 | Completed Phase 1

• 1 other identifier: CI-PSI-004-02-101
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.

Conditions

HIV Infections

Keywords

treatment experienced; HIV; Phase I; Combination Therapy

Interventions

Racivir DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects may be eligible to participate if they:
• Are males with HIV infection with a positive HIV antibody test
• Have an HIV-RNA copy number of ≥ 5000 copies/ml (Roche assay)
• Have CD4+ cell counts ≥ 50 cells/ml
• Are 18-45 years of age, inclusive
• Have a body mass index (BMI) ≥ 18 kg/m2
• Are antiretroviral nucleoside reverse transcriptase inhibitor-naive
• Have read and understand the informed consent,and is able and willing to comply with study procedures

You may not qualify if:

• Subjects may not participate if they:
• Have clinically significant ECG abnormalities
• Have clinically significant abnormalities in any safety laboratory parameters
• Have an ALT value ≥ 3xUNL
• Have previously participated in this trial
• Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug
• Have a history of chronic alcohol or drug abuse within the last 6 months
• Have a positive urine drug screening
• Have a positive alcohol breath test
• Have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject's ability to participate in this trial
• Have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol

Sponsors & Collaborators

• Pharmasset: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Racivir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 24, 2002
• First Posted: June 25, 2002
• Study Start: June 1, 2002
• Study Completion: December 1, 2002
• Last Updated: July 21, 2005

Record last verified: 2005-07