Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT00001133
Eligibility Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
* Are HIV-positive.
* Are at least 18 years old.
* Have a viral load (level of HIV in the blood) of at least 500 copies/ml but no more than 100,000 copies/ml within 45 days of study entry.
* Have been taking the following anti-HIV drug combination for at least 12 weeks before study entry: 2 NRTIs plus amprenavir (APV), nelfinavir (NFV), saquinavir (SQV), or NFV plus SQV.
* Are naive to at least 1 NRTI. This means that there is at least 1 NRTI that the patient has not taken for more than 14 days. In the case of lamivudine (3TC), naive means that the patient has never taken this drug.
* Are willing and able to drink 1.5 liters (a little over 1.5 quarts) of water or other fluids a day.
* Agree to use an effective barrier method of birth control (such as condoms) during the study and for 3 months after.
Exclusion Criteria
Patients will not be eligible for this study if they:
* Have taken protease inhibitors other than APV, NFV, SQV, or NFV plus SQV.
* Are resistant to the effects of IDV or RTV, as shown by a blood test. (Patients whose viral load is between 500 and 1,000 copies/ml will not need to be tested.)
* Have any active opportunistic (AIDS-related) infection in the 14 days before study entry.
* Have any medical condition or history of disease that would prevent them from completing the study or put them at risk.
* Have cancer that requires chemotherapy.
* Have an active infection that requires treatment in the 14 days before study entry.
* Have a fever for a week or more in the 30 days before study entry.
* Have taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) in the 30 days before study entry.
* Have received a vaccine in the 21 days before study entry.
* Have received an experimental drug or a drug that affects the immune system in the 30 days before study entry.
* Have taken or plan to take certain other medications that may affect the study.
* Are pregnant or breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00001133
Study Brief:
Protocol Section:
NCT00001133