Early Versus Standard Start of Anti-HIV Therapy for Treatment-Naive Adults in Haiti
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Purpose
Anti-HIV treatment consisting of lamivudine/zidovudine (3TC/ZDV) and efavirenz (EFV) is the current standard of care for initial treatment of HIV in most areas of the world. The purpose of this study is to determine the best time to start this anti-HIV treatment in treatment-naive adults in Haiti.
| Condition | Intervention |
|---|---|
|
HIV Infections Tuberculosis |
Drug: Efavirenz Drug: Lamivudine/Zidovudine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Clinical Trial to Determine the Efficacy of Early Versus Standard Antiretroviral Therapy in HIV Infected Adults With CD4+ T Cell Counts Between 200 and 350 Cells/mm3 |
- Survival [ Time Frame: At 36 months ] [ Designated as safety issue: No ]
- Safety and drug-associated side effects and toxicities of the study drugs [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Pattern and frequency of antiretroviral drug resistance during ART [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Occurrence and clinical outcome of opportunistic infections, viral coinfections, and immune reconstitution syndromes observed during ART [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- TB treatment outcomes in patients with active pulmonary TB at enrollment [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Quality of life scores based on self-report questionnaires [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Adherence based on self-report questionnaires and dosage count [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Cost of therapy [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Plasma HIV-1 RNA below limits of quantitation after initiating ART [ Time Frame: Every 6 months throughout study ] [ Designated as safety issue: No ]
- Absolute CD4 cell count change from baseline in subjects who initiate ART [ Time Frame: Every 6 months throughout study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 794 |
| Study Start Date: | July 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Randomly assigned group who will start an ART regimen of 3TC/ZDV and EFV twice daily at study entry
|
Drug: Efavirenz
Non-nucleoside reverse transcriptase inhibitor dosed at 600mg taken by mouth every 24 hours at bedtime
Other Name: EFV
Drug: Lamivudine/Zidovudine
Nucleoside reverse transcriptase inhibitor dosed at 150mg/300mg fixed dose combination taken by mouth every 12 hours
Other Names:
|
|
Active Comparator: B
Randomly assigned group who will delay beginning ART regimen of 3TC/ZDV and EFC twice daily until they develop clinical AIDS or their CD4 count drops below 200 cells/mm3
|
Drug: Efavirenz
Non-nucleoside reverse transcriptase inhibitor dosed at 600mg taken by mouth every 24 hours at bedtime
Other Name: EFV
Drug: Lamivudine/Zidovudine
Nucleoside reverse transcriptase inhibitor dosed at 150mg/300mg fixed dose combination taken by mouth every 12 hours
Other Names:
|
Detailed Description:
In many parts of the world, initial standard of care for HIV includes 3TC/ZDV and the non-nucleoside reverse transcriptase inhibitor EFV. However, it is unclear if early (CD4 count less than 350 cells/mm3) or delayed (CD4 count less than 200 cells/mm3) therapy initiation leads to improved survival. This study will determine the most appropriate time to initiate ART in HIV infected individuals in Haiti. The study will enroll patients from the Haitian Study Group on Kaposi's Sarcoma and Opportunistic Infections (GHESKIO) Centers. Some participants in this study will have active pulmonary tuberculosis (TB).
This study will last at least 3 years. Participants will be randomly assigned to one of two groups at study entry. Group A participants will receive 3TC/ZDV twice daily and EFV once daily at study enrollment. Participants receiving TB therapy at the time of enrollment may be observed for 2 weeks prior to beginning early therapy. Dosage adjustment of EFV may be necessary for participants receiving rifampin as part of their TB therapy. Group B participants will receive 3TC/ZDV twice daily and EFV once daily when they develop clinical AIDS or their CD4 count drops below 200 cells/mm3 (WHO Stage IV). Directly observed therapy will be used for the first two months of treatment for every participant.
Group A participants will have 14 study visits after beginning treatment; the visits will occur at Months 1, 2, 3, and every 3 months thereafter. Medical and medication history, physical exams, and contraceptive counseling for women will occur at all visits. HIV counseling, blood collection, and HIV staging will occur at most visits. At some study visits, Group A participants will be asked to complete quality of life and adherence questionnaires. Group B participants will have 14 study visits after study entry and will begin treatment when they meet WHO criteria. Assessments will be the same as for Group A. Any participant who fails the first-line regimen during the study will switch to a second-line ART regimen.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-infected
- Received pre- and post-test counseling at the GHESKIO Centers
- CD4 count between 200 and 350 cells/mm3
- World Health Organization (WHO) Stage I, II, or III HIV disease
- Willing to use acceptable forms of contraception
Exclusion Criteria:
- WHO Stage IV HIV disease (AIDS)
- 7 or more days of cumulative ART prior to study entry OR on ART at time of study entry
- Active TB, if diagnostic work-up for TB is incomplete OR if decision to treat TB has not been made. More information on this criterion can be found in the protocol.
- Recurrent active TB OR history of interrupted or incomplete TB therapy. More information on this criterion can be found in the protocol.
- Has not been evaluated for latent TB and decision to treat latent TB with isoniazid has not been made. More information on this criterion can be found in the protocol.
- Requires ART in the next 3 months, in the opinion of the investigator
- Other serious medical illness requiring chronic maintenance therapy (e.g., hypertension, diabetes) UNLESS the individual has completed at least 14 days of therapy prior to study enrollment AND is clinically stable
- Any psychological condition (e.g., severe depression, schizophrenia) that, in the opinion of the investigator, may interfere with the study
- Any social condition (e.g., pending emigration, pending incarceration) that, in the opinion of the investigator, may interfere with the study
- Active drug or alcohol use that, in the opinion of the investigator, may interfere with the study
- Current inflammation of the pancreas
- Allergy/sensitivity to any of study drugs or their formulations
- Requires certain medications
- Enrolled in another therapeutic or interventional clinical trial
- Pregnant or breastfeeding
Contacts and Locations| Haiti | |
| GHESKIO Centers | |
| Port au Prince, Haiti | |
| Principal Investigator: | Jean William Pape, MD | Cornell - GHESKIO, Institut de Laboratoire et de Recherches and Division of International Medicine and Infectious Diseases, Cornell University |
| Study Director: | Patrice Severe, MD | Cornell - GHESKIO, Institut de Laboratoire et de Recherches |
| Study Director: | Daniel W. Fitzgerald, MD | Division of International Medicine and Infectious Diseases, Cornell University |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rona Siskind, DAIDS |
| ClinicalTrials.gov Identifier: | NCT00120510 History of Changes |
| Other Study ID Numbers: | CIPRA HT 001, 5-K24-AI051966-03 |
| Study First Received: | July 14, 2005 |
| Last Updated: | September 23, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Disease (NIAID):
|
Treatment Naive TB |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Zidovudine Lamivudine Reverse Transcriptase Inhibitors Efavirenz Lamivudine, zidovudine drug combination Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 16, 2012
