A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Regimens in HIV Infected Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether it is better to start an anti-HIV regimen containing a protease inhibitor (PI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or a PI in combination with an NNRTI. This study will also examine which treatment regimen is best as a first treatment for HIV infection.

Detailed Description
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Highly active antiretroviral therapy (HAART) regimens containing PIs, NNRTIs, or nucleoside reverse transcriptase inhibitors (NRTIs) have been shown to slow disease progression. However, the long-term consequences of initial therapy with a PI, an NNRTI, or both a PI and an NNRTI are not yet known, nor is the impact on future anti-HIV treatment regimens. Patients who experience virologic failure on a particular HAART regimen typically have not been studied for subsequent response to other HAART regimens. It is possible that a regimen which is initially the most potent may not be optimal if it limits the effectiveness of subsequent anti-HIV treatment regimens. Patients will be randomized to one of three HAART treatment arms: Arm 1 participants will receive one or two PIs plus two NRTIs. Arm 2 participants will receive one NNRTI plus two NRTIs. Arm 3 participants will receive one or two PIs plus an NNRTI plus one or two NRTIs. Before randomization to a treatment arm, patients will be given the option of preselecting the drugs they will use or allowing randomization to study-specified drugs. The study-specified PIs will be indinavir (IDV), nelfinavir (NFV), or two PIs of patient and doctor choice. The study-specified NNRTIs will be nevirapine (NVP) or efavirenz (EFV). The study-specified NRTIs will be abacavir (ABC) plus lamivudine (3TC) or didanosine (ddI) plus stavudine (d4T). The study sites will provide ABC, 3TC, ddI, or d4T to all patients who are assigned to take these medications. All other anti-HIV drugs for initial and subsequent treatment regimens are obtained by clinician prescription. At Months 1 and 4 and then every 4 months thereafter, patients will receive a medical history update, physical exam, and questionnaire. Blood samples will also be drawn to measure CD4 cell count, viral load, and genotypic antiretroviral resistance. Changes in treatment regimens may occur at any time.

Official Title
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A Randomized, Open-Label Study of the Long-Term Effectiveness of Three Initial Highly Active Antiretroviral Therapy (HAART) Strategies in HAART-Niave, HIV-Infected Persons

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Indinavir sulfate
* Drug: Abacavir sulfate
* Drug: Nelfinavir mesylate
* Drug: Efavirenz
* Drug: Nevirapine
* Drug: Lamivudine
* Drug: Stavudine
* Drug: Didanosine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infected Agree to practice abstinence or to use barrier methods of birth control during the study Are at least 13 years old or have signed informed consent from legal guardian for patients between the ages of 13 and 18 Exclusion Criteria: Have ever taken any anti-HIV drugs Are unable to complete the study for any reason Pregnancy Breastfeeding Any condition that, in the investigator's opinion, may interfere with the study

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Abacavir sulfate|nan|
|Drug: Nelfinavir mesylate|nan|
|Drug: Efavirenz|nan|
|Drug: Nevirapine|nan|
|Drug: Lamivudine|nan|
|Drug: Stavudine|nan|
|Drug: Didanosine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CD4 count from baseline to the average of all readings obtained at the regular follow-up visits beginning at Month 32 |  |  | 
| time to disease progression, death, or CD4 count less than 200 cells/mm3 at the 4 Month visit for those patients with a baseline CD4 cell count of more than or equal to 200 cells/mm3 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy, Combination, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Treatment Naive