A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy
Completed · Phase 4
Conditions studied: HIV Infections
In brief
We hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction phase of HAART therapy will lead to faster clearance of virus and infected cells, and lower number of minority variant HIV-1 strains.
Key facts
- Study ID
- NCT00344760
- Run by
- University of Maryland, Baltimore
- People needed
- 2
- Starts
- 2005-01-01
- Expected to finish
- 2007-03-01
- Last updated by the study team
- 2021-05-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age: 18 to 70 years of age.
- Sex: Male or Female.
- Documented HIV-1 seropositive by Western Blot, Elisa, or HIV-1 viral load.
- Naïve to HAART.
- Viral load >100,000c/ml.
- CD4<200c/ml.
- Volunteers must be willing and able to provide written informed consent to participate in the study.
- Available for at least 48 weeks of follow-up.
You may not qualify if…
- Volunteers with an acute and clinically significant medical event as determined by the investigator to result in a life expectancy less then 12 months despite ART.
- Volunteers with current psychiatric illness, alcohol abuse or illicit drug use that in the opinion of the Principal Investigator may interfere with patient's ability to comply with protocol requirements.
- Renal insufficiency (Estimated Creatinine clearance of <60ml/min.)
- Patients with malabsorption or severe chronic diarrhea for more than 30 days.
- Inability to consume adequate oral intake (defined as inability to eat at least 1 meal per day).
- Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- Any other medical condition which, in the opinion of the investigator, might interfere with completion of the study or evaluation of the results.
- Pregnancy or breastfeeding
- In a female capable of child bearing, unwillingness to use effective barrier contraception or abstinence
- Patient who is currently receiving an experimental medication.
Where it is running
- University of Maryland, Institute of Human Virology — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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