The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients

What Was Tested

In this phase 3 trial, researchers set out to test L-Carnitine.

It had two arms (groups): 1 (experimental) and 2 (experimental).

Participants will receive adefovir dipivoxil and L-carnitine.

Participants will receive adefovir dipivoxil placebo and L-carnitine.

The registry classes the interventions as drug.

More on the Plan

All patients will be enrolled within the first 18 months of the study.

They will be randomized to 1 of 2 groups.

Group 1 will be comprised of 1080 patients and will receive adefovir dipivoxil plus L-carnitine and group 2 will be comprised of 1080 patients and will receive a placebo plus L-carnitine.

At least the first 400 patients enrolled (200 in each group) will comprise the safety-HIV virology cohort.

Who Took Part

Enrollment: 505 actual participants took part.

It was open to people of any sex aged from 13 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Short courses of oral antibiotics or other therapies given for a limited period of 3 weeks. A working diagnosis of HIV infection based on the patient's medical history, behavioral history, clinical signs and symptoms, or results of other laboratory tests. Reasonably good health. Life expectancy of at least 6 months. Access to a refrigerator for the storage of adefovir dipivoxil.

The full record lists 10 inclusion and 37 exclusion criteria; among the exclusions: evidence of active cmv disease at screening; conditions that would require use of medications listed in exclusion concurrent medications; any investigational anti-cmv agent.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant and care provider.

It started in 1996-12 with completion listed for 1999-01.

It ran at 15 sites in United States (15).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Morbidity (time frame: Throughout study).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 505 people.

With 505 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.