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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients  Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 175
Location and Contact Information:
Cornell Clinical Trials Unit - Chelsea Clinic
New York City, New York, 10011
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
CRI New England
Brookline, Massachusetts, 02445
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213
United States
Univ of Alabama at Birmingham / 1917 Rsch Cln
Birmingham, Alabama, 35294
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Grady Mem Hosp
Atlanta, Georgia, 30308
United States
Thomas Street Clinic
Houston, Texas, 77009
United States
Amelia Ct Clinic
Dallas, Texas, 75235
United States
San Francisco Veterans Adm Med Cntr
San Francisco, California, 94121
United States
Hillsborough County Health Dept Special Care Ctr
Tampa, Florida, 33605
United States
Tower Infectious Disease Med Ctr
Los Angeles, California, 90048
United States
AIDS Research Consortium of Atlanta Inc
Atlanta, Georgia, 30308
United States
UCSD Treatment Ctr
San Diego, California, 92103
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Hershey Med Ctr
Hershey, Pennsylvania, 17033
United States
Northstar Med Clinic
Chicago, Illinois, 60657
United States
McDowell Clinic
Phoenix, Arizona, 85016
United States
Private Practice / Thacker and Thompson
Atlanta, Georgia, 30324
United States
Roger Williams Med Ctr
Providence, Rhode Island, 02908
United States
Univ Hosps of Cleveland
Cleveland, Ohio, 44106
United States
Additional Information:
Study ID Numbers: 283B; GS-98-902
Study Start Date:
Record last reviewed: November 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002415
Other Hiv Infections Studies:
1. Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success with Protease Inhibitor-Containing HAART Regimen(s)
2. A Study of Patients Who Recently Have Been Infected with HIV
3. A Phase I/II Trial of Ribavirin (With Escalation) + Isoprinosine in Asymptomatic HIV-Viremic Patients
4. Effects of Changing HIV Therapy at Lower Versus Higher Viral Loads
5. A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis carinii Pneumonia in AIDS
Related Studies:
Other HIV Infections Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients
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