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Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen Clinical research trials and Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen. Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen clinical trial. Subjects often receive the most expert healthcare possible for their Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen  Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen
Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: ACTG 388 was a clinical trial that compared three- and four-drug anti-HIV drug regimens and demonstrated the effectiveness of a three-drug regimen. This study will compare the ability of two different three-drug anti-HIV drug regimens to reduce levels of HIV in the blood. The study will also evaluate whether patients discontinue the regimens because of drug side effects.
Details: ACTG 388 was designed to evaluate two four-drug regimens compared with a three-drug regimen in patients who were relatively treatment naive. Based on the increased complexity and toxicity of four-drug regimens and the resultant negative impact on response as compared with three-drug regimens, studies evaluating simplified potent regimens appear warranted. This study will evaluate simpilified drug regimens designed to enhance virologic activity without necessarily increasing the number of antiretroviral drugs. The study regimens will be assessed for both virologic control and tolerability. The study population will include patients previously enrolled in ACTG 388 and patients with prior advanced HIV disease who received and responded to potent antiretroviral therapy without evidence of virologic relapse. Patients will be stratified according to ACTG 388 treatment or non-ACTG 388 study participation. Patients will then be randomized to receive either a protease inhibitor (PI)-sparing regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) with efavirenz (EFV) (Arm I) or an NRTI-sparing regimen of EFV with lopinavir/ritonavir (LPV/r) (Arm II). Arm I options are enteric-coated didanosine (ddI-EC) plus lamivudine (3TC), ddI-EC plus zidovudine (ZDV), ZDV plus 3TC (or Combivir), stavudine (d4T) plus 3TC, or ddI-EC plus d4T (with exceptions as noted in the protocol). Only LPV/r, EFV, d4T, and ddI are provided by the study; other medications are obtained by nonstudy prescription. All patients are evaluated for safety and for virologic and immunologic responses at Weeks 4 and 8, then every 8 weeks until the study ends. In addition, all patients have assessments for fat redistribution, fasting lipid profiles, fasting insulin levels, venous lactate levels, and treatment adherence. Patients will be followed for 1.5 to 3 years. Interim safety analyses will be conducted in June 2002 and June 2003. Patients in this study may also enroll in A5125s, a fat distribution and bone mineral density substudy.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria for ACTG 388 Participants - HIV-1 RNA level <= 200 copies/ml within 70 days of study entry - Stable anti-HIV drug plan without harmful drug side effects or serious illness at the time of study entry Inclusion Criteria for Non-ACTG 388 Participants - Potent anti-HIV drug regimen as a first HIV treatment for at least 18 months - HIV-1 RNA level >= 80,000 copies/ml or CD4+ count <= 200 cells/mm3 prior to starting anti-HIV drug regimen - HIV-1 RNA level <= 400 copies/ml (or less than 500 copies/ml by bDNA) within 32 weeks of initial therapy - HIV-1 RNA level <= 200 copies/ml within 60 days of study entry Inclusion Criteria for Both ACTG 388 and Non-ACTG 388 Participants - Acceptable methods of contraception - Consent of parent or legal guardian if under 18 years of age Exclusion Criteria for ACTG 388 Participants - Viral resistance to study drugs as determined by resistance studies during ACTG 388 Exclusion Criteria for ACTG 388 and Non-ACTG 388 Participants - Pregnancy or breastfeeding - Certain heart medicines (flecainide or propafenone); antihistamines (astemizole and terfenadine); rifampin; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, or methylergonovine); intestinal agents (cisapride); herbal products (St. John's wort); lovastatin or simvastatin; neuroleptics (pimozide); and sedatives/hypnotics (midazolam or triazolam) - Allergy study drugs
Total Enrollment: 240
Location and Contact Information:
Overall Study Official:
MargaretFischl, Study Chair, University of Miami
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Denver Dept of Health and Hosps
Denver, Colorado, 80262
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
The CORE Ctr
Chicago, Illinois, 60612
United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Connecticut Children's Medical Center (Pediatric)
Farmington, Connecticut, 06030-3805
United States
Universita degli Studi di Modena e Reggio Emilia
Modena, ,
Italy
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Univ of Washington
Seattle, Washington, 98104
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Universita di Genova
Genova, ,
Italy
Cornell Clinical Trials Unit - Chelsea Clinic
New York City, New York, 10011
United States
Spedali Civili - Carosi
Brescia, ,
Italy
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Wishard Hosp
Indianapolis, Indiana, 46202
United States
Washington Univ / St Louis Connect Care
St. Louis, Missouri, 63108
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Washington Univ School of Medicine
St. Louis, Missouri, 63108
United States
Ospedale Luigi Sacco Milazzo
Milano, ,
Italy
Additional Information:
Study ID Numbers: ACTG A5116; Substudy AACTG A5125s,Substudy AACTG A5124s,AACTG 5116
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014937
Other Hiv Infections Studies:
1. A Phase I Safety and Immunogenicity Trial of HIV-1 gp120 C4-V3 Hybrid Polyvalent Peptide Immunogen Mixed in Mineral Oil Containing Mannose Mono-Oleate (IFA)
2. A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients with AIDS
3. A Phase II Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of the Recombinant HIV-1 Envelope Vaccines SF-2 rgp120 (CHO) [Chiron Vaccines] in MF59 Adjuvant and MN rgp120/HIV-1 [VaxGen] in Alum Adjuvant in Healthy Adults
4. Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
5. The Effect of Teaching HIV-Infected Patients about HIV and Treatment
Related Studies:
Other HIV Infections Clinical Trials
Other Clinical Trials
Other San Juan Clinical Trials
Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen
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