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Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients Clinical research trials and Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients. Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients clinical trial. Participants oftentimes recieve the most expert healthcare available for their Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients  Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients
Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb
Synopsis: The purpose of this study is to determine the safety and effectiveness of stavudine (d4T), didanosine (ddI), and BMS-232632 when given early in the course of HIV infection. Acute HIV infection may develop in patients that are exposed to the HIV virus. Following infection, the viral load (level of HIV in the blood) rises rapidly over the next few days to weeks. It is not known which is the best treatment in patients with very early HIV infection. Researchers believe these patients may respond well to strong early treatment. A combination consisting of enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease inhibitor, BMS-232632, will be tested.
Details: Acute primary HIV-1 infection (PHI) follows exposure to the HIV-1 virus and results in a rapid rise in plasma viremia within days to 1 to 3 weeks. Individuals with acute PHI or early HIV-1 infection represent a potentially unique patient population in which to evaluate potent antiretroviral therapies because of the degree of viral heterogeneity and the fact that immunologic disruption is likely to be lower than in later stages of HIV-1 disease. The optimal treatment for acute PHI is unknown. This study evaluates a regimen consisting of enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease inhibitor, BMS-232632. Patients are enrolled into Group I or Group II and may participate in substudies. Patients in Group I receive ddI-EC, d4T, and BMS-232632 daily for 52 weeks. Clinical, virologic, and immunologic evaluations are performed on Days 2, 7, 14, 21, and 28, then every 4 weeks through Week 24, and then every 8 weeks thereafter through Week 48. Based on laboratory results from the Week 48 visit, a decision is made by Week 52 whether or not to continue study medications for an additional 52 weeks. Evaluation schedules for those patients enrolled in substudies may be different. Group II patients elect not to receive antiretroviral treatment and are followed as a natural history disease group to be compared with patients in Group I. They are followed according to the same schedule of evaluations as those enrolled in Group I, unless otherwise specified as part of their participation in substudies. All patients are followed in this study at 8-week intervals for a total duration of 104 weeks (2 years). HIV will be measured in plasma and tissues to determine reduction in replication for a duration of at least 48 weeks. The 3 substudies in which patients may participate are AI-03-006, Lymphoid Tissue Substudy; AI-03-007, Immunology Substudy of cytolytic and co-stimulatory markers, T-cell repertoire, and cytokine and chemokine elaboration; and AI-03-008, Viral Dynamics and Diversity Substudy.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Have early HIV infection or show recent seroconversion (going from HIV-negative to HIV-positive). - Are at least 18 years old. - Agree to 2 barrier methods of birth control, if heterosexually active men or women, during the study and for 3 months after. Exclusion Criteria Patients will not be eligible for this study if they: - Have received prior antiretroviral therapy. - Have received interferons, interleukins, colony-stimulating factors, radiation, cytotoxic chemotherapy, or HIV vaccines within 30 days prior to study entry. - Have had any experimental therapy within 30 days prior to study entry. - Are pregnant or breast-feeding. - Patients will not be eligible for Group I if they: - Have had pancreatitis (inflammation of the pancreas). - Have received alpha tocopherol (vitamin E), amiodarone, astemizole, carbamazepine, cisapride, ergotamine/diergotamine, estrogens, fluvastatin, glucocorticoids, itraconazole, ketoconazole, midazolam, phenobarbital, phenytoin, quinidine, rifampin, rifabutin, sildenafil, statin drugs (simvastatin, pravastatin, atorvastatin) used for reduction of triglyceride or cholesterol levels, terfenadine, triazolam, or warfarin within 14 days of study entry. - Have received chloramphenicol, cisplatin, clioquinol, dapsone, diphenylhydantoin, disulfiram, ethionamide, glutethimide, gold, hydralazine, isoniazid, metronidazole, pyridoxine, sodium cyanate, thalidomide, vincristine, or zalcitabine within 30 days of study entry. In certain cases, patients taking these drugs may still be eligible.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
ConstanceBenson, Study Chair,
AIDS Research Consortium of Atlanta *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Dr Thompson 404-876-2317
Rush Presbyterian - Saint Luke's Med Ctr *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Jan Fritsche 312-942-5865
Centro de Referencia Estadual de AIDS (CREAIDS) *Recruiting*
Salvador da Bahia, ,
Brazil
Recruiting Eduardo Netto 55-71-235-4901
Univ of Colorado Health Sciences Ctr *Recruiting*
Denver, Colorado, 80262
United States
Recruiting Graham Ray 303-372-5535
Northwestern Univ *Recruiting*
Chicago, Illinois, 60611-3015
United States
Recruiting Baiba Berzins 312-695-5012
Additional Information:
Study ID Numbers: AIEDRP AI-03-005; Substudy AI-03-007,Substudy AI-03-008,Substudy AI-03-006
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007202
Other Hiv Infections Studies:
1. A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in HIV-1 Seropositive Women During the Last Trimester of Pregnancy and Their Newborns
2. Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
3. The Effectiveness of Human Antibodies in Influencing an AIDS-Like Disease in Monkeys
4. Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
5. The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients with HIV and Cryptococcal Meningitis
Related Studies:
Other HIV Infections Clinical Trials
Other Georgia Clinical Trials
Other Atlanta Clinical Trials
Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients
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