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Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients



Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients

For Condition: HIV Infections
Status: Completed
Sponsor(s): Abbott Laboratories ,
Synopsis: The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus.
Details:
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Have HIV Infection. - Age 18 to 65 years old. - Show no signs of recent illness other than HIV infection. - Agree to use a barrier method of birth control during the study and for 30 days after study. Exclusion Criteria: - Are unable to follow study requirements (in the opinion of the investigator). - Are pregnant or breast-feeding. - Are unable to take medications by mouth. - Have chronic nausea or vomiting. - Have cancer other than Kaposi's sarcoma or basal cell carcinoma. - Have active, serious infections (other than HIV) requiring antibiotic injections within 15 days prior to screening. - Are taking any medications that are not allowed with ABT-378/r and efavirenz. - Are taking or have taken any other experimental drugs, antiretroviral drugs, or drugs that affect the immune system within 30 days of start of study without consent of the medical monitor. - Are receiving or have received radiation therapy within 30 days of start of study without consent of the medical monitor. - Have a history of drug abuse or mental illness that would prevent the patient from following the protocol requirements. - Have a history of kidney or bone disease.
Total Enrollment: 

Location and Contact Information:

Aaron Diamond AIDS Research Center - Rockefeller University
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:  M00-154; 
Study Start Date: July 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038220

Other Hiv Infections Studies:
1. HIV Incidence and Participation Retention in Pune, India

2. The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children

3. A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group

4. Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals

5. A Study of Azithromycin in HIV-Infected Patients

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