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Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination with Nelfinavir in HIV-Positive Children Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination with Nelfinavir in HIV-Positive Children conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination with Nelfinavir in HIV-Positive Children Clinical research trials and Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination with Nelfinavir in HIV-Positive Children health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination with Nelfinavir in HIV-Positive Children. Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination with Nelfinavir in HIV-Positive Children Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination with Nelfinavir in HIV-Positive Children clinical trial. Human subjects often get the best healthcare available for their Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination with Nelfinavir in HIV-Positive Children condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination with Nelfinavir in HIV-Positive Children  Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination with Nelfinavir in HIV-Positive Children
Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination with Nelfinavir in HIV-Positive Children
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with NFV. Cohort II: The purpose of this study is to see how safe it is to give EFZ syrup combined with NFV and to measure the levels of EFZ and NFV in the blood. (This purpose reflects a change from the original since there are now 2 different cohorts of patients.) EFZ is an effective anti-HIV medication that easily can be combined with other drugs to treat HIV. This is an early study to determine a safe and effective dose for HIV-positive children. This study also will examine the correct dose of NFV to use in combination with EFZ.
Details: The demonstrated antiviral activity, tolerability, and pharmacokinetic properties of DMP 266 and its utility in combination with other agents make DMP 266 an attractive agent for use in HIV-infected pediatric patients. However, the tolerability of DMP 266 in the pediatric population must be evaluated, and appropriate dosing instructions need to be developed. By following the patients over time, the antiviral activity of DMP 266-containing regimens will be documented. Dosage guidelines for children can then be developed following analysis of the results. This is a 48-week [AS PER AMENDMENT (APA) 12/21/98:104-week] [APA 5/8/00: 208-week] study. It is designed to minimize the chance that ineffective therapy is provided (short dose-escalation phase) and utilizes an area under the concentration time curve (AUC) to establish plasma levels of DMP 266 and nelfinavir in the pediatric population that are both tolerable and efficacious. [APA 5/26/98: Patients are stratified by age into Cohorts I and II] and receive EFV concurrently with NFV. [APA 5/26/98: The initial starting dose of DMP 266 for patients in Cohort II is higher than the initial starting dose for patients in Cohort I.] [APA 12/21/98: The initial starting dose for patients in Stratum 1 of Cohort II is higher than the initial starting dose for patients in Cohort I and Stratum 2 of Cohort II.] The initial target AUC for DMP 266 is between 190 and 380 micromoles/h (uM/h). The initial starting dose (based on a 70 kg patient and adjusted for each patient's weight) for the first 6 patients is adjusted on the basis of tolerability and plasma concentrations of DMP 266 after 2 weeks of daily doses. If at least 4 of the first 6 patients attain a tolerable dose (dose at which no more than 2 of 6 patients experience Grade 3 or worse toxicity) and target AUC, additional patients may continue to be accrued. However, if any of the initial 6 patients experience life-threatening toxicity, further accrual is suspended. [APA 5/26/98: An assessment of the tolerability and plasma concentrations of EFV is not required in an initial group of Cohort II patients. Individual dose is based on pharmacokinetic sampling.] Patients receive a given starting dose of DMP 266 and continue on that dose until individual dose adjustments are needed. If a patient's starting dose is tolerated but the target AUC is not achieved, the dose is increased. If the starting dose is well tolerated and target AUC achieved, no adjustment in starting dose is given to future patients. If no tolerated dose achieving at least an AUC of 150 micromoles/h is reached in 4 of 6 patients, the study is suspended and alternative dosing regimens, e.g., twice-daily dosing, are considered. A patient's current dose of DMP 266 is adjusted based on how the dose is tolerated and whether the target AUC is achieved. If a patient does not achieve an AUC of greater than 110 micromoles/h and experiences Grade 3 or worse toxicity, the patient is discontinued from the study. [APA 12/21/98: The dose of NFV is the same for patients in Cohort I and Stratum 2 of Cohort II; the dose for patients in Stratum 1 of Cohort II is higher.] The minimum target AUC for NFV is 10 mg x h/L. Doses are adjusted for an individual child if AUC falls below threshold at Week 2 or 6. Children with weight no greater than 30 kg receive a lower dose than children with weight greater than 30 kg or Tanner Stage IV. [APA 5/8/00: The first group of 6 patients receives the initial dose of NFV. If none of the 6 patients falls below the target AUC, the remainder of the sample is accrued and treated at this dose. If more than 1 of the 6 patients fall below the target AUC, then another group of 6 patients is accrued and treated at the next higher dose. If exactly 1 of the 6 patients falls below the target AUC, 2 more patients are accrued and treated at the same dose. If 1 of these 2 patients falls below the target AUC, another group of 6 patients is tested on the next higher dose. If neither of these 2 patients falls below the target AUC, then the remainder of the sample is accrued and treated at this dose. The dose is escalated until a dose that meets the above criteria is achieved or further dose escalation is prohibited due to toxicity.] The duration of therapy is 48 [APA 12/21/98:104] [APA 5/8/00: 208] weeks.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 3 Months/16 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Children may be eligible for this study if they: - Are HIV-positive. - Are between 3 months and 16 years old (consent of parent or legal guardian required). (These age requirements reflect a change.) - Have a plasma viral load of at least 400 copies/ml at screening. - Agree to practice abstinence or use effective methods of birth control during the study. - Are able to take oral medication and comply with study requirements. - Are taking at least 1 nucleoside reverse transcriptase inhibitor (NRTI), such as zidovudine (ZDV) or stavudine (d4T). Patients can begin taking NRTIs at the beginning of the study. Exclusion Criteria Children will not be eligible for this study if they: - Have had more than 2 episodes of moderate to severe diarrhea or vomiting lasting more than 4 days within 3 months prior to study entry. - Are allergic to EFZ or NFV. - Have any disease, including hepatitis, cancer, or an active opportunistic (HIV-associated) infection. - Are pregnant or breast-feeding. - Are taking any other experimental drugs or certain medications. - Have ever taken protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs).
Total Enrollment: 105
Location and Contact Information:
Overall Study Official:
CourtneyFletcher, Study Chair,
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Harlem Hosp Ctr
New York City, New York, 10037
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Earl K Long Early Intervention Clinic
New Orleans, Louisiana, 70112
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Additional Information:
Study ID Numbers: ACTG 382; PACTG 382
Study Start Date: October 1997
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000893
Other Hiv Infections Studies:
1. A Study of the Safety and Effectiveness of an HIV Vaccine for HIV-Positive Patients Receiving Anti-HIV Drugs for at Least 2 Years
2. A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
3. A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3
4. An Open Trial Combining Zidovudine, Interferon-alfa, and Recombinant CD4-IgG With Transplantation of Syngeneic Bone Marrow and Peripheral Blood Lymphocytes From Healthy gp160-Immunized Donors in the Treatment of Patients With HIV Infection
5. A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy
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Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination with Nelfinavir in HIV-Positive Children
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