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

Sponsor:	Pharmasset
Information provided by:	Pharmasset
ClinicalTrials.gov Identifier:	NCT00040300

Purpose

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

Condition	Intervention	Phase
HIV Infections	Drug: Racivir	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: 2',3'-Dideoxy-5-fluoro-3'-thiacytidine

U.S. FDA Resources

Further study details as provided by Pharmasset:

Estimated Enrollment:	18
Study Start Date:	June 2002
Estimated Study Completion Date:	December 2002

Detailed Description:

The study is a 14-day study with a 21-day follow-up period. During the 14-days of active study period, participants will receive Racivir once daily in combination with efavirenz and stavudine. Following the administration of the first and last dose of study medication, patients will remain in the clinic overnight. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, EKGs, and routine clinical laboratory tests.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00040300 History of Changes
Other Study ID Numbers:	CI-PSI-004-02-101
Study First Received:	June 24, 2002
Last Updated:	July 18, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pharmasset:

treatment experienced
HIV
Phase I
Combination Therapy

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases

Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
2',3'-dideoxy-5-fluoro-3'-thiacytidine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012