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:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT00089466
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infected
* Have X4- or dual/mixed-tropic virus confirmed no more than 56 days prior to study entry
* HIV-1 viral load of 5,000 copies/ml or more within 60 days prior to study entry
* If female, willing to discontinue hormonal contraception 1 week prior to study entry
* Willing to use acceptable forms of contraception
Exclusion Criteria:
* Antiretroviral treatment within 14 days prior to study entry
* Other prescription medications, herbal supplements, or aspirin within 7 days prior to study entry. Patients taking medication for prophylaxis for Pneumocystis carinii pneumonia (PCP) are not excluded. Patients taking medications approved by protocol officials are not excluded, provided they have been on a stable dose for at least 14 days prior to study entry.
* Nonsteroidal anti-inflammatory drugs (NSAIDS), over the counter medications, or other supplements (including multivitamins) within 1 day prior to study entry
* Heavy exercise within 24 hours before study entry evaluations are done
* Immunizations within 30 days prior to study entry
* Radiation therapy, cytotoxic chemotherapeutic agents, or immunomodulatory agents within 30 days prior to study entry
* Current use of some CYP substrates, inhibitors, or inducers. Use of CYP450 substrates is allowed, except for CYP2D6 and CYP2C8 substrates.
* Current use of P-gp inducers or inhibitors
* Allergy or sensitivity to study drug or its formulations
* Active infection or acute illness within 14 days prior to study entry, including HIV-associated opportunistic infections
* History of heart abnormalities. Patients with any repolarization delay (QTc interval of greater than 500 msec) or a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia) are also excluded.
* Drug or alcohol abuse or dependence or other medical or psychological condition that, in the opinion of the investigator, would interfere with the study or put participants at undue risk
* Chronic diarrhea, defined as having more than 3 stools/day for more than 4 weeks prior to study entry
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00089466
Study Brief:
Protocol Section:
NCT00089466