Current partner codePEPTIDESDE
NCT00102934·Not applicable·INTERVENTIONAL

Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus

Status

Unknown

Phase

Not applicable

Enrollment

20

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

Drug resistance may develop in HIV infected patients who take anti-HIV drugs, but most patients do well if they continue taking them. The purpose of this study is to test the effectiveness of a short, intensified course of anti-HIV drugs for controlling HIV infection in adults who have virus resistant to multiple drugs.

Full detailed description

While an HIV infected patient is taking highly active antiretroviral therapy (HAART), drug-resistant HIV may emerge; however, it has been observed that HIV viral loads while on HAART are usually lower than baseline levels. Expansion of the T cell population during early HAART may explain this phenomenon. It is hoped that a short but aggressive HAART regimen to treatment-experienced patients who have drug-resistant virus will produce immune cells that will better control drug-resistant virus. This study will determine if a 6-month HAART regimen intensified by enfuvirtide (T-20) is effective in eliciting a stronger immune response against drug-resistant virus. This study will last 48 weeks. All participants will receive T-20 as part of a HAART intensification regimen; HAART other than T-20 will not be provided by the study. There will be 17 study visits. Prior to beginning treatment intensification, participants will have weekly study visits for three weeks. Once treatment intensification has started, participants will be followed weekly for four weeks, then weekly for four weeks after treatment intensification, then monthly thereafter. Blood collection will occur at each visit.

Interventions

Treatment arms and agents.

DRUG

Enfuvirtide-intensified HAART

90 mg tablet taken orally twice daily

Timeline

From registration to results.

  1. First posted

    Feb 7, 2005

  2. Study start

    Mar 2003

  3. Primary completion

    Dec 2005

  4. Study completion

    Mar 2009

  5. Results posted

    Not reported

  6. Registry updated

    Sep 17, 2008

Outcomes

What the study measures.

Primary outcomes

HIV viral load

Time frame · Throughout study

Secondary outcomes

Frequency of HIV-specific T cells

Time frame · Thoughout study

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * HIV viral load of more than 1000 copies/ml * On stable antiretroviral therapy * Have multidrug resistance Exclusion Criteria: * Require immunomodulatory drugs

Study locations

1 registered sites.

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

San Francisco General Hospital

San Francisco, California, 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.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.