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Home > "A" Clinical Trials Conditions > Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents  Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents
Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents
For Condition: HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: This study will compare the effectiveness of anti-HIV drug regimens with or without a protease inhibitor (PI) in HIV infected adolescents. It will also determine if monitoring drug levels and adjusting the dose as necessary improves the effectiveness of these regimens.
Details: HIV infected adolescents may have a significantly higher capacity for immune reconsitution following highly active antiretroviral therapy (HAART). Despite this advantage, HIV infected adolescents are often reluctant to get proper medical care, follow through with doctor appointments, and adhere to medication schedules and regimens necessary to keep the infection under control. Lopinavir/ritonavir, a PI, and efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI), both have long half-lives that make them ideal drugs for the adolescent population, as they are more forgiving if patients miss or sleep through doses. This study will examine the effectiveness of two HAART regimens, one with the protease inhibitor lopinavir/ritonavir and two nucleoside reverse transcriptase inhibitors (NRTIs), and the other with the NNRTI efavirenz and two NRTIs. The efficacy of therapeutic drug monitoring (TDM) and subsequent dose adjustment will also be assessed with both regimens. Patients will be enrolled in this study for 96 weeks (slightly less than 2 years) and will be randomly assigned into one of two groups. Group 1 will receive lopinavir/ritonavir and 2 NRTIs; Group 2 will receive efavirenz and 2 NRTIs. All patients will be independently and simultaneously randomly assigned to receive either TDM with subsequent dose adjustment if necessary or no TDM or dose adjustment. Patient medical history and physical exam will be conducted at screening, entry, and Weeks 2, 4, 16, 32, 40, 48, 60, 72, 84, and 96. Blood work will be completed at screening, entry, and Weeks 2, 4, 8, 16, 24, 32, 40, 48, 60, 72, 84, and 96. Self-reported pill counts and MEMS TrackCap readings (on lopinavir/ritonavir and efavirenz bottles) will be noted at Weeks 2, 4, 16, 32, 48, 60, 72, 84, and 96. Adherence Questionnaire Modules 1 and 2 will be given to patients at selected visits. Patients enrolled in PACTG 390 (Different Combination Regimens and Treatment-Switching Guidelines in HIV Infected Children 18 Years of Age and Younger) are encouraged to co-enroll simultaneously in this study and in PACTG 219C (Long-Term Effects of HIV Exposure and Infection in Children).
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/23 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - HIV infected - HIV RNA 10,000 copies/ml or more at screening - Weigh 35 kg (77.2 lbs) or more - ART naive or received a single regimen of combination therapy consisting of NRTIs with or without a single PI (except lopinavir). Zidovudine monotherapy during pregnancy or use of low-dose ritonavir as a PI boost are not excluded. - For PI experienced patients, have sensitivity to lopinavir at screening - Able to receive, as part of background ART chosen by their physician, at least one new NRTI that is likely to be active against the patient's virus and unlikely to have cross-resistance with previously used NRTIs - Not pregnant at screening - Willing to use acceptable forms of contraception - Parent, legal guardian, or patient informed consent, where applicable Exclusion Criteria: - Prior receipt of any NNRTI or lopinavir - Use of certain medications - Grade 3 or 4 clinical or laboratory toxicity as defined by the Division of AIDS Toxicity Table for Grading Severity of Pediatric Adverse Effects - Chemotherapy for active malignancy - Acute opportunistic or serious bacterial infection requiring therapy at study entry - Investigational treatment within 30 days of study entry - Score of 20 or more on Beck Depression Inventory (BDI-II) or suicidal thoughts on BDI-II (score of 2 or 3 on Question 9), regardless of total score - Pregnant or breastfeeding
Total Enrollment: 240
Location and Contact Information:
Overall Study Official:
MargaritaSilio, Study Chair, Tulane Medical Center
Cook County Hospital
Chicago, Illinois, 60612
United States
Rachel Jackson 312-572-4554
Tulane University, Charity Hospital of New Orleans
New Orleans, Louisiana, 70112-2699
United States
Margaret Cowie 504-586-3804
Mt. Sinai Medical Center
New York City, New York, 10029
United States
John D'agostino 212-241-5341
Chicago Childrens Memorial Hospital (Pediatric)
Chicago, Illinois, 60614
United States
Stacy Rogers 773-880-3669
St. Jude Children's Research Hopital, Memphis
Memphis, Tennessee, 38105-2794
United States
Laura Utech 901-495-3490
Childrens Hospital Los Angeles
Los Angeles, California, 90027
United States
Cathleen Salata 323-669-2390
Univ. of Puerto Rico, U. Childrens Hospital AIDS
San Juan, , 00936-5067
Puerto Rico
Sylvia Davila 787-759-9595
State University of New York at Stony Brook
Stony Brook, New York, 11794-8111
United States
Denise Ferraro 631-444-8225
Childrens Hospital of Boston
Boston, Massachusetts, 02115
United States
Kirk Bertelsen 617-355-8198
St. Louis Children's Hospital
St. Louis, Missouri, 63110
United States
Laura Pickering 314-454-2576
Additional Information:
Study ID Numbers: PACTG P1034;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075907
Other Hiv Infections Studies:
1. Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen
2. A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir
3. Male Circumcision and HIV Rates in Kenya
4. Screening Protocol for HIV Vaccine Studies
5. A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined with MF59 in HIV-1 Uninfected Adult Volunteers
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Stony Brook Clinical Trials
Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents
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