Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients - Tabular View

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Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients

This study has been completed.

Study NCT00002415. Last updated on June 23, 2005. Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
Official Title ^†	A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Antiviral Activity of the Addition of PMPA Prodrug to Combination Antiretroviral Regimens in Treatment-Experienced HIV-Infected Patients
Brief Summary	The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied.
Detailed Description	Prior to study entry patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs. PMPA Prodrug or placebo is added to current antiretroviral regimens, and is administered in one of three dosing regimens. Patients randomized to receive placebo are eligible to receive open-label PMPA Prodrug for the remainder of the 48-week study period after at least 24 weeks post randomization.
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Double-Blind, Safety Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: Tenofovir disoproxil fumarate
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	175
Start Date ^†
Completion Date
Eligibility Criteria ^†	Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have an HIV count of 400 - 50,000 copies/ml. Are expected to live for at least 1 year. Have been taking the same anti-HIV drug combination (made up of no more than 3 anti-HIV drugs) for at least 8 weeks prior to study entry. Are at least 18 years old. Agree to use effective methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: Have taken medications for certain infections within 15 days prior to study entry. Have a history of cancer, except Kaposi's sarcoma (KS) or skin cancer. Develop a new AIDS-related condition within 30 days of study entry. Have certain serious medical conditions, including severe nausea, vomiting, or other stomach problems that make you unable to take medications by mouth. Have received a vaccine within 30 days prior to study entry. Have taken certain medications, including those that may affect your kidneys. Abuse alcohol or drugs. Are pregnant.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00002415
Organization ID	283B
Secondary IDs ^††	GS-98-902
Study Sponsor ^†	Gilead Sciences
Collaborators ^††
Investigators ^†
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	November 1999
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.