Once-Daily PI/NNRTI Therapy Combinations for Treatment Naive, HIV Infected Patients in Resource-limited Conditions - Article Sustiva
Clinical Trial: Once-Daily PI/NNRTI Therapy Combinations for Treatment Naive, HIV Infected Patients in Resource-limited Conditions
This study is not yet open for patient recruitment.
Taking anti-HIV drugs correctly is important to control HIV viral load and avoid drug resistance. Less complicated drug dosing may help promote medication adherence. This study will compare the effectiveness of 3 three-drug combinations in HIV infected patients starting their first HIV treatment regimens. Participants will be recruited from resource-poor communities in Africa, Asia, South America, Haiti, and the U.S.
|Condition||Treatment or Intervention||Phase|
|HIV Infections || Drug: Atazanavir |
Drug: Didanosine, enteric coated
Drug: Tenofovir disoproxil fumarate
|Phase IV |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Phase IV, Prospective, Randomized, Open-Label Evaluation of the Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Individuals from Resource-Limited Setting (PEARLS) Trial
Expected Total Enrollment: 1520
In developed countries, standard effective anti-HIV therapy for treatment-naive HIV infected patients includes three-drug combinations of two nucleoside reverse transcriptase inhibitors (NRTIs) with either a protease inhibitor (PI) or a nonnucleoside reverse transcriptase inhibitor (NNRTI). However, many HIV infected patients in resource-poor countries do not receive proper medical care for HIV infection. Medication adherence is a problem observed in all groups of HIV infected patients; non-adherence may be lessened with simplified medication dosing. This study will compare the effectiveness of 3 three-drug combinations in treatment-naive HIV infected patients in resource-limited settings. Patients for this trial will be recruited in Africa (Malawi, South Africa, Zimbabwe), Asia (India, Thailand), South America (Brazil, Peru), Haiti, and the United States.
Patients in this study will be randomly assigned to one of three arms. Arm A patients will receive lamivudine/zidovudine twice daily and efavirenz once daily. Arm B patients will receive emtricitabine, atazanavir, and enteric-coated didanosine once daily. Arm C patients will receive emtricitabine, tenofovir disoproxil fumarate, and efavirenz once daily.
This study will last approximately 48 weeks. A physical exam and blood collection will occur at entry and at ten study visits. Pill counts and patient interviews about adherence to their regimens will also occur at each visit. A patient experiencing virologic failure and either progression to AIDS or a significant decrease in CD4 cell count will be offered a switch from their current regimen to another regimen. Participants are encouraged to enroll in substudy A5185s, a study of HIV viral load in genital secretions.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Inclusion Criteria for Step 1:
- HIV-1 infected
- Prior antiretroviral therapy for less than 7 days any time prior to study entry
- CD4 count less than 300 cells/mm3
- Willing to use acceptable means of contraception
- Plans to stay in the area for the duration of study participation
- Willing to adhere to study follow-up schedule
Exclusion Criteria for Step 1:
- Acute therapy for serious medical illnesses within 14 days prior to study entry. Patients with serious infection who must continue with chronic maintenance therapy must be clinically stable and have completed at least 14 days of therapy prior to study entry.
- Any condition that, in the opinion of the site investigator, would compromise the patient's ability to participate in the study
- Radiation therapy or chemotherapy within 45 days prior to study entry. Systemic chemotherapy for treatment of Kaposi's sarcoma within 45 days of study entry is acceptable, provided the systemic chemotherapy is completed prior to entry.
- Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry. Patients taking tapered courses of corticosteroids for acute therapy for Pneumocystis carinii pneumonia (PCP) are not excluded.
- Current alcohol or drug abuse that, in the opinion of the site investigator, would interfere with study requirements
- Inflamed pancreas
- Allergy to any of the study drugs or their formulations
- Heart rate less than 40 beats/min
- History of untreated active 2nd or 3rd degree heart block
- Certain medications
- Currently detained in jail or for treatment of a psychiatric or physical illness
- Vomiting or inability to swallow medications
Harbor General/UCLA, Torrance, California, 90502-2052, United States
UCLA School of Medicine, Los Angeles, California, 90095-1793, United States
Univ. of Colorado Health Sciences Center, Denver, Denver, Colorado, 80262-3706, United States
Washington University (St. Louis), St. Louis, Missouri, 63108-2138, United States
Chelsea Clinic, New York, New York, 10011, United States
Columbia University, New York, New York, 10032-3784, United States
University of North Carolina, Chapel Hill, North Carolina, 27514, United States
The Moses H. Cone Memorial Hospital, Greensboro, North Carolina, 27401-4001, United States
Wake County Department of Health, Chapel Hill, North Carolina, 27514, United States
Duke University Medical Center, Durham, North Carolina, 27710, United States
University of Pennsylvania, Philadelphia, Philadelphia, Pennsylvania, 19104, United States
Presbyterian Medical Center - Univ. of PA, Philadelphia, Pennsylvania, 19104, United States
The Miriam Hospital, Providence, Rhode Island, 02906, United States
Rhode Island Hospital, Providence, Rhode Island, 02906, United States
Stanley Street Treatment and Resource, Providence, Rhode Island, 02906, United States
Comprehensive Care Clinic, Nashville, Tennessee, 37203, United States
University of Texas, Galveston, Galveston, Texas, 77555-0435, United States
University of North Carolina Project (UNC Project), Lilongwe, Malawi
University of Witwatersrand, Johannesburg, South Africa
University of Zimbabwe, Harare, Zimbabwe
Thomas B. Campbell, MD, Study Chair, University of Colorado
Timothy Flanigan, MD, Study Chair, Miriam Hospital
James Hakim, MscClinEpi, FRCP, Study Chair, Department of Medicine, University of Zimbabwe
Nagalingeswaran Kumarasamy, MD, Study Chair, YRG Centre for AIDS Research and Education
Click here for more information about atazanavir
Click here for more information about didanosine
Click here for more information about efavirenz
Click here for more information about emtricitabine
Click here for more information about lamivudine/zidovudine
Click here for more information about tenofovir disoproxil fumarate
Click here for more information about nucleoside reverse transcriptase inhibitors [NRTIs]
Click here for more information about non-nucleoside reverse transcriptase inhibitors [NNRTIs]
Click here for more information about protease inhibitors [PIs]
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Record last reviewed: April 2005
Last Updated: April 7, 2005
Record first received: June 7, 2004
ClinicalTrials.gov Identifier: NCT00084136
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005