Current partner codePEPTIDESDE
NCT00344760·Phase 4·INTERVENTIONAL

A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy

Status

Completed

Phase

Phase 4

Enrollment

2

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

This is an 48 week Phase 4, open label, randomized, prospective, pilot proof of concept study to evaluate the use of Enfuvirtide in an induction/maintenance treatment model. Patients meeting inclusion criteria will be stratified into two groups according to HIV-1 RNA viral loads (less than 300,000 copies/ml and greater than 300,000 copies/ml). Thereafter, patients will be block randomized (the size of each block will be two patients) into one of two treatment arms. All patients will receive Efavirenz 600mg once a day, Lamivudine 300 mg once a day, and Tenofovir 300mg once a day. After randomization, one half of the patients will receive no additional treatment, while the other half will receive Enfuvirtide 90mg sq BID until the viral load is \<50 x 2 consecutive visits or 12 weeks (whichever comes first).

Interventions

Treatment arms and agents.

DRUG

Enfuvirtide

subcutaneously twice a day

DRUG

Efavirenz, lamivudine, and tenofovir

Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily

Timeline

From registration to results.

  1. First posted

    Jun 27, 2006

  2. Study start

    Jan 2005

  3. Primary completion

    Mar 2007

  4. Study completion

    Mar 2007

  5. Results posted

    Not reported

  6. Registry updated

    May 11, 2021

Outcomes

What the study measures.

Primary outcomes

Time to viral suppression below 50c/ml.

Time frame · Individual

The study is 48 weeks long and the time to viraL suppression will vary depending on the subject. Or there is the possibility that they do not supress

Secondary outcomes

Log viral copy/ml decrease over time during phase 1 and phase 2.

Time frame · Over the 48 week study period

Development of clinical mutations.

Time frame · Over the 48 week study period

Development of sub-clinical mutations (minority variants)

Time frame · Over the 48 week study period

Viral suppression (below 50c/ml) at 24 and 48 weeks.

Time frame · At 24 and 48 weeks

Time to loss of viral response. Loss of viral response defined as:

Time frame · Over the 48 week study period

Less then 2.0 log decrease in viral load at week 8.

Time frame · Week 8

Inability to achieve Viral load <50c/ml by week 12.

Time frame · Week 12

Viral load >50c/ml on 2 consecutive measurements taken 2 weeks apart after viral

Time frame · Over the 48 week study period

suppression <50c/ml has occurred

Time frame · Over the 48 week study period

Rate and quantity of HIV-1 proviral DNA decay.

Time frame · Over the 48 week study period

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. Age: 18 to 70 years of age. 2. Sex: Male or Female. 3. Documented HIV-1 seropositive by Western Blot, Elisa, or HIV-1 viral load. 4. Naïve to HAART. 5. Viral load \>100,000c/ml. 6. CD4\<200c/ml. 7. Volunteers must be willing and able to provide written informed consent to participate in the study. 8. Available for at least 48 weeks of follow-up. Exclusion Criteria: 1. 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. 2. 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. 3. Renal insufficiency (Estimated Creatinine clearance of \<60ml/min.) 4. Patients with malabsorption or severe chronic diarrhea for more than 30 days. 5. Inability to consume adequate oral intake (defined as inability to eat at least 1 meal per day). 6. Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. 7. Any other medical condition which, in the opinion of the investigator, might interfere with completion of the study or evaluation of the results. 8. Pregnancy or breastfeeding 9. In a female capable of child bearing, unwillingness to use effective barrier contraception or abstinence 10. Patient who is currently receiving an experimental medication.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

University of Maryland, Institute of Human Virology

Baltimore, Maryland, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Enfuvirtide.

Related PeptideStat pages

Put the record in context.

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